Cardiovasc Intervent Radiol DOI 10.1007/s00270-016-1344-z

CIRSE STANDARDS OF PRACTICE GUIDELINES

CIRSE Standards of Practice Guidelines on Gastrostomy James Sutcliffe1 • Andrew Wigham1 • Niall Mceniff2 • Petr Dvorak3 Laura Crocetti4 • Raman Uberoi1

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Received: 2 June 2015 / Accepted: 6 April 2016  Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2016

Abstract Purpose Surgical Gastrostomy has been around since the 19th century but in 1980 the first successful percutaneous endoscopic gastrostomy was reported. A year later the first successful percutaneous gastrostomy was performed using fluoroscopic guidance. The technique for percutaneous insertion and the equipment used has been refined since then and it is now considered the gold standard for gastrostomy insertion. Here we present guidelines for imageguided enteral feeding tubes in adults. Material and Method We performed a review and analysis of the scientific literature, other national and international guidelines and expert opinion. & Raman Uberoi [email protected] James Sutcliffe [email protected] Andrew Wigham [email protected] Niall Mceniff [email protected] Petr Dvorak [email protected] Laura Crocetti [email protected] 1

Radiology Department, Oxford University Hospitals NHS Trust, Oxford, UK

2

Radiology (DiagIm), St. James’s Hospital, Dublin, Ireland

3

Radiology Department, Faculty Hospital Charles University, Prague, Czech Republic

4

Diagnostic Imaging and Intervention, Department of Hepatology and Liver Transplants, University of Pisa, Pisa, Italy

Results Studies have shown fluoroscopic techniques have consistently higher success rates with lower rates of major complications than endoscopic techniques. However, the Achilles’ heel of many fluoroscopic techniques is the requirement for smaller gastrostomy tube sizes resulting in them being more prone to blockages and thus requiring further intervention. Conclusion Radiological feeding tube insertion is a safe and effective procedure. Success rates are higher, and complication rates lower than PEG or surgical gastrostomy tube placement and innovative techniques for gastric and jejunal access mean that there are very few cases in which RIG is not possible. The principal weakness of radiologically inserted gastrostomies is the limitiation on tube size which leads to a higher rate of tube blockage. Per-oral image-guided gastrostomies have to an extent addressed this but have not been popularised. Currently many centres still consider endoscopic gastrostomies as the first line unless patients are too unwell to undergo this procedure or previous attempts have failed, in which case radioloically inserted gastrostomies are the technique of choice. Keywords Gastrojejunostomy/percutaneous endoscopic gastrostomy (PEG)  Radiologically inserted gastrostomy (RIG)  Per-oral image-guided gastrostomy (PIG)  Subspecialty/technique  Enteral feeding  Sub-specialty/technique  Non-vascular interventions  Specialty  Gastrointestinal  Organ  Stroke  Disease

Introduction Malnutrition is prevalent in hospital inpatients with studies showing that 29–33 % of hospital inpatients are malnourished [1, 2], while almost 43 % of patients were at risk of

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malnutrition [2]. Access for enteral nutrition may be considered for any patient with a functional gastrointestinal tract but who is unable to swallow safely [3]. Beyond basic hydration and nutrition, the aim of enteral feeding is to attenuate the metabolic response to stress, prevent oxidative cell injury and to favourably modulate the immune response [3]. Gastrostomy feeding is a well-established technique to enable long-term enteral feeding for those patients in whom oral intake is either not possible or unsafe, and early gastrostomy feeding has been shown to improve recovery from ischaemic stroke and reduce overall complications from gastrostomy insertion [4, 5]. Surgical gastrostomy has been performed since the nineteenth century, but requires a general anaesthetic, which is associated with high morbidity, and mortality, and consequently, it has been replaced by percutaneous methods. In 1980, Gauderer and Ponsky [6] described the first successful percutaneous technique with the aid of endoscopy. A year later, Preshaw described the first successful percutaneous technique using fluoroscopic guidance [7]. His technique, commonly referred to as radiologically inserted gastrostomy (RIG), has now been established as a safe and effective technique for enteral nutrition or gastric decompression. Percutaneous endoscopic gastrostomy (PEG) has traditionally been the gold standard for gastrostomy insertion. It is readily available and allows primary insertion of large bore gastrostomy tubes. One of the perceived advantages of endoscopic gastrostomy insertion is the ‘free’ endoscopic examination and potential for therapeutic intervention [8]. However, more recent studies dispute this, Laasch et al. [9] demonstrated peptic disease in 21 % of patients undergoing gastrostomy (not unexpected in starved patients) an 8.5 % incidence of other benign gastric pathology, which did not alter patient management and no undiagnosed malignancies. Other disadvantages of PEG tube insertion include the increased risk of wound infection due to contamination with oral flora and the potential for tumour seeding in head and neck cancer cases. The image-guided techniques, per-oral image-guided gastrostomy (PIG) [10] and RIG [11] are usually successful where PEG has failed, or in clinical scenarios where PEG cannot be performed including a tight stenosis of the upper GI tract, a large hiatus hernia or significant obesity where trans illumination is difficult [10–12]. In addition, endoscopic gastrostomy insertion almost always requires conscious sedation, which may be contraindicated in patients with neuromuscular weakness. In contrast, consistently high success rates for placement of RIG tubes are reported (95–100 %) [13, 14]. In their meta-analysis, Wollman et al. [15] found rates of successful RIG placement to be 99.2 versus 95.7 % for PEG. They also found the prevalence of major complications

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rates were lower in the RIG group—5.9 versus 9.4 % for PEG [15]. However, more recent studies have demonstrated similar complications rates [10]. The principal disadvantage of a pure percutaneous method is the smaller sizes of tubes usually used in this technique, which are more prone to blockage and may require fluoroscopic guidance when exchanged [9, 12]. Modifications of the percutaneous technique allow per-oral placement of the gastrostomy tube enabling larger bore tubes to be inserted [9, 11, 12, 16]. Primary placement of button type catheters that are less prone to occlusion has also been described [12, 17]. This document contains guidelines including the indications, personnel specification, procedural steps, postprocedure care and outcomes of image-guided enteral feeding tubes in adult patients. It is based on review and analysis of the available literature, other national and international guidelines and expert opinion. It is not intended as a set of unconditional instructions and the judgement of the responsible healthcare professional, based on the complexities of each case, must take precedence over the recommendations offered here. Nevertheless, it is anticipated that the following will provide direction in many of the situations encountered when inserting and maintaining gastrostomy tubes. Definitions Enteral Feeding The delivery of nutrients directly into the stomach, duodenum or jejunum. Gastrostomy A stoma from the skin to the stomach through which a tube is placed to allow additional nutritional support or sometimes for gastric decompression. Transabdominal Access The gastrostomy tube is inserted through the abdominal wall into the stomach. Transoral Access The gastrostomy is inserted into the mouth and pulled or pushed into the stomach. Neurogenic Dysphagia Neurogenic dysphagia is a disorder characterised by difficulty in swallowing. It occurs as a result of nervous system

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disorders such as stroke, motor neuron disorders, traumatic brain injury, cerebral palsy, Parkinson’s disease and multiple sclerosis. Radiologically Inserted Gastrostomy (RIG) Radiologically inserted gastrostomy was first described in 1981 by Preshaw [7]. It is a Seldinger technique in which the stomach is insufflated with air following the passage of a nasogastric tube or peroral catheter. A needle is then passed percutaneously into the stomach under fluoroscopic guidance and a wire passed through the needle. A gastrostomy tube is then passed over the wire. Percutaneous Endoscopic Gastrostomy (PEG) Percutaneous endoscopic gastrostomy was first described in 1980 by Gauderer and Ponsky [6]. It is an endoscopic technique in which a gastroscope is passed orally into the stomach, which is then insufflated with air. A trocar is then passed percutaneously into the stomach and a gastrostomy tube passed, using either a ‘‘push’’ or ‘‘pull’’ technique. Per-Oral Image-Guided Gastrostomy (PIG) In 1988, a hybrid technique was developed known as peroral image-guided gastrostomy (PIG) that allowed the passage of larger gastrostomy tubes [18]. Like RIG, PIG is a Seldinger technique in which the stomach is punctured first, and the oesophagus catheterised in a retrograde fashion. A guidewire is passed out of the patient’s mouth and the gastrostomy advanced over the wire through the oropharynx, through the oesophagus and stomach and out of the gastrostomy site.

can be passed from the mouth at the beginning of the procedure. Before performing RIG, it is essential to identify a ‘safe window’ for gastric puncture avoiding the left lobe of the liver and in particular the transverse colon. This is usually straight forward on fluoroscopy, but CT may be required in patients with complex surgical history or large hiatus hernia to establish whether there is a safe percutaneous window for insertion. If difficulties are anticipated with fluoroscopic guidance, such as difficult access to the stomach or interposed colon, CT guidance is recommended [11, 12]. Some operators advocate oral/nasogastric contrast media, e.g. 100 ml barium sulphate, 50–100 % W/V, administered 24 h before gastrostomy to opacify the large bowel. In a recent UK multicentre survey, only 17 % of cases were performed following the administration of oral contrast media. Although this is a cheap and reliable method to visualise the colon, there is no evidence available to establish whether this decreases the incidence of colonic injury [20]. Ultrasound can be used to delineate the liver and bowel prior to the procedure. The study by Lowe et al. [20] showed that 30 % of cases were performed with ultrasound to identify these structures. Indications Patients to be considered for gastrostomy should be at high-risk of malnutrition and be unlikely to recover their ability to feed orally in the short term [21], or those who require long-term gastric decompression [12, 22–24]. These include patients with disorders such as •

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Gastropexy Gastropexy is the method of apposing the anterior wall of the stomach to the anterior abdominal wall. Percutaneous gastropexy was first described in 1986 by Brown et al. [19] and is performed in order to prevent the stomach being pushed away during catheterisation and to reduce the risk of peritoneal leakage. It is usually performed with metal T-fasteners introduced percutaneously with special needles or surgical sutures. Pre-treatment Imaging Adequate gastric distension by insufflation of air is essential for gastrostomy placement. For radiological placement, this can be done through a pre-existing nasogastric tube. Alternatively a standard angiography catheter

Neurogenic dysphagia with high risk of aspiration

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Cerebrovascular event [9, 21, 25, 26] Traumatic brain injury where there is cognitive impairment and depressed consciousness [9, 21, 27, 28] Cerebral palsy [9, 21] Neurodegenerative syndromes [9, 21]

Head and neck malignancy—where there is local neurological involvement, physical tumour obstruction [29] or where side-effects of the treatment such as radiotherapy and chemotherapy prevent adequate oral nutrition [9, 21, 30] Oral/throat surgery [21, 30] Endoscopy contraindicated or PEG failed [9, 21] Gastric decompression/diversion—bowel rest in GI fistulae [12] Patients with impaired absorption due to systemic illnesses such as

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• • • •

Crohn’s disease [21, 29, 31–33] Systemic sclerosis [29, 34] Radiation enteritis [21, 29]

Patients requiring additional nutritional supplementation • • • • •

Severe burns [35, 36] Hydrocephalus [29] Severe congenital heart disease [29] Anorexia [21] Profound depression [1].

The role of gastrostomy in decompressing small-bowel obstruction from end-stage malignancy, the so-called venting gastrostomy, remains to be defined. Contraindications Absolute There are few absolute contraindications to enteral access. These include • • • • •

Uncorrected coagulopathy Active peritonitis Bowel ischaemia GI tract obstruction (unless the indication is decompression) Patients with portal hypertension and gastric varices, which can bleed profusely.

Relative

recommended to ensure against the recurrence of large volume ascites which can cause dislodgement even with gastropexy placement [38]. Previous surgery such as Billroth partial gastrectomy, and oesophagectomy with gastric pull through increase the complexity of the procedure but careful planning and technique modifications, such as utilisation of CT guidance for gastric puncture and balloon dilatation of the stomach, may render the procedure possible [29]. Colonic interposition is a relative contraindication, but the utilisation of infracolic methods have been shown to be successful [39]. In this situation, additional punctures from gastropexy increase the risk of vascular injury in the transverse mesocolon. Neurological disorders may result in diaphragmatic denervation and a superiorly displaced stomach. The same applies to large hiatus herniae or gastric volvuli. To overcome such difficulties, an angled sub-costal or intercostal approach has been successfully utilised with no additional morbidity [40]. The placement of a gastrostomy in patients with a ventriculoperitoneal shunt may increase the risk of ascending meningitis [41]. Patients on long-term steroids or immunosuppression are predisposed to infective complications leading to stoma retraction and have been found to be at higher risk of peritubal leakage [42]. Open wounds, previous incisional hernia mesh repairs or adjacent stoma sites are not absolute contraindications, and if a suitable window away from the area can be identified, then gastrostomy can be performed.

There are a number of conditions that represent relative contraindications to enteral access. These include:

Patient Selection and Preparation

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Patient selection for gastrostomy is critical and the decision whether it is appropriate should be based on the principles of beneficence and non-maleficence. In certain patient groups, this is relatively straightforward. For example, in patients with dysphagia following stroke, it has been shown that over half will recover their neurologic function, and gastrostomy feeding can provide valuable enteral nutrition in the interim [43]. However, there is controversy surrounding the insertion of gastrostomy tubes in patients with advanced dementia and terminal malignancy. No consistent benefit has been shown from gastrostomy insertion in these patients [12, 44]. If symptoms of thirst, hunger or dry mouth are expressed these are usually transient and can usually be alleviated with small amounts of food, fluids and/or by the application of ice chips and lubrication to the lips [44]. The mortality rate in patients with advanced dementia is not altered by gastrostomy tube placement as the death rate is more related to the underlying condition and co-morbidities [45]. In fact, gastrostomy tube

• • •

Ascites Billroth partial gastrectomy Large hiatus hernia and gastric volvulus Oesophagectomy with gastric pull through Colonic interposition Diaphragmatic denervation with superiorly displaced stomach Ventriculoperitoneal shunt Patients on long-term steroids or immunosuppression Open wounds, previous incisional hernia mesh repairs and adjacent stoma sites.

The presence of ascites has previously been regarded as an absolute contraindication, due to the risk of bacterial peritonitis, impaired track maturation and risk of tube migration if the ascites re-accumulates. Gastrostomy may be performed following paracentesis and gastropexy is mandatory to prevent peri-tubal leakage and tube [37]. Ultrasound follow-up and repeat paracentesis is

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placement may actually have a negative effect on patients quality of life due to the loss of hand feeding and the associated touch, taste and social interaction [25] and due to the occasional need to chemically or physically restrain patients to prevent them from dislodging the tube [12, 43, 46]. The current literature supports an individual but critical and restrictive approach to gastrostomy feeding in dementia patients [33]. To ensure correct patient selection for gastrostomy, all cases must be discussed in a multidisciplinary meeting, including the supervising clinician, the interventional radiologist, the speech therapist and the dietician. Once the decision has been made that gastrostomy placement is appropriate, then the patient should be assessed on the ward by the interventional radiologist and if possible informed consent should be obtained. A significant number of patients undergoing RIG are unable to give informed consent and institutional protocols for patients lacking capacity should be followed. The patient, their family and caregivers should be fully included in discussions at all stages, but the ultimate decision lies with the patient and in cases of reduced capacity the medical team. In some patients, such as those with neuromuscular disorders or tracheostomies, anaesthetic support may be required to ensure safe administration of sedation. If so, anaesthetic review should be arranged prior to the procedure. Haematological and coagulation screens should be reviewed and acted upon accordingly. Gastrostomy placement is classified as a category 2 procedure with a moderate risk of bleeding in the recently published consensus guidelines for peri-procedural management of coagulation status [47]. These guidelines make a number of recommendations (1) target haematological parameters are an INR \ 1.5 and platelets [ 50 9 109/L, (2) If the patient is on low molecular weight heparin then the dose before the procedure should be stopped, (3) clopidogrel should be stopped 5 days before the procedure and (4) aspirin can be continued. However, given the often diverse array of patient variables, comorbidities and concomitant haemostatic defects management should always be tailored to the individual patient. The patient should have an empty stomach and any enteral feeding should be stopped 12 h pre-procedure. A final safety checklist should be completed in the perioperative setting prior to any anaesthetic. Two common examples are the WHO surgical safety checklist for radiological interventions [48] and the CIRSE interventional radiology checklist [49]. Non-invasive monitoring equipment should be applied and BP, pulse and oxygen saturations should be monitored throughout the procedure. The skin should be prepared using standard aseptic technique and sterile drapes applied.

Personnel Specification Ideally, the interventional team should consist of an interventional radiologist, an operating assistant, a nurse for supervision of the patient and observation monitoring, a radiographer and an anaesthetist and anaesthetic assistant if required. However, though desirable this is not always possible. Nonetheless, the team should consist of at least one radiologist experienced in the procedure, a nurse who is trained to administer analgesia and sedation and who can monitor the patient and a trained radiographer. The operator should have appropriate image interpretation skills appropriate to gastrostomy insertion [50] and sufficient training in radiation protection to allow optimisation of medical exposures [51, 52]. The European Commission’s Council Directive 97/43/EURATOM establishes in Article 7 that member states shall ensure that practitioners should have adequate and theoretical practical training for the purposes of radiological practices, as well as relevant competence in radiation protection [53]. Competency to perform the procedure should be evaluated locally, based upon national/international training guidelines. Structured assessment tools for assessing competency are being increasingly utilised in interventional radiology training [54]. Currently, there is no requirement for trainees to complete an examination at the end of their training which identifies their skills as an interventional radiologist. However, the Cardiovascular and Interventional Radiology Society of Europe, the European Society of Radiology and the European Union of Medical Specialists Interventional Radiology Division now organise and endorse the European Board of Interventional Radiology examination which aims to standardise training across Europe and give patients and colleagues confidence in interventional radiology [55]. No specific number of procedures has been shown to equate to individual competency. Nevertheless following formal training, it would be prudent to have performed at least five supervised procedures under indirect supervision by an experienced operator prior to gaining independent practitioner status. Two experienced practitioners should perform complex cases. The operator should keep a log of cases and complications, and local arrangements should be in place to allow regular audit of outcomes and complications. Equipment Specifications The procedure should be performed with fluoroscopic image intensification and should provide diagnostic image quality and recording. The equipment should be capable of an accelerating voltage [100 kVp. Digital subtraction angiography is not necessary.

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The facility should have equipment for non-invasive monitoring of vital signs, supplemental oxygen, suction for the oral cavity and upper respiratory tract and be able to respond to life-threatening emergencies. An ultrasound machine should be available with a low frequency curvilinear probe in cases where hepatomegaly is suspected. Ward placement of nasogastric tubes can save time but if this is not possible a selective 5–6Fr per-oral catheter, for example a cobra or vertebral configuration, with a hydrophilic guidewire can be quick and easily performed in the department. A 50-ml syringe will also be required for gastric insufflation. Gastric distension is improved by intravenous administration of a smooth muscle relaxant such as hyoscine butylbromide or glucagon. Standard materials include the following: gastropexy sutures; 18G needle for gastric puncture; hydrophilic and stiff 0.035 guidewires; serial dilators; peel-away sheath of appropriate size (for balloon-retained device); and gastrostomy tube. Most gastrostomy sets include the requisite equipment. Contrast is required for confirmation of intragastric placement. The modified PIG technique requires a haemostatic vascular sheath and may require snares. Angioplasty balloons may be required for track dilation and length measurement if button type devices are being inserted. A number of gastropexy devices are available. They consist of a metal T-bar fastener attached to a suture and a mechanism to enable suture fixation outside the skin. A needle, pre-loaded with the T-fastener, is passed into the stomach and following aspiration of air its intragastric positioned is confirmed by the injection of contrast. The T-fastener is then pushed through the needle into the stomach and the needle removed. Traction can then be applied to the T-fastener allowing gastric wall apposition and the suture is fixed. Care should be taken to avoid excessive traction on the sutures as gastric deflation at the end of the procedure increases tension on the sutures. Traditional gastropexy sutures were made of non-absorbable nylon; absorbable gastropexy sutures are now available which obviate the need for suture removal. There are numerous commercially available gastrostomy tubes. The type of tube should be selected based on the patient requirements: Loop Retained Tubes These are 10–14F polyurethane tubes held in place by a loop in the catheter, which is formed by traction on a retaining string once intragastric position is confirmed. They can be placed rapidly and safely often with only local anaesthetic, which may be advantageous in patients with

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neuromuscular weakness. The relatively narrow calibre and long length leads to high occlusion rates [11] and tube rotation or degradation of the locking thread by gastric acid can lead to tube displacement [22]. Balloon Retained Tubes These tubes are retained by a balloon filled with water and are available in sizes from 10 to 22Fr. Though larger in calibre than loop retained tubes the size of the lumen is reduced due to relatively thick silicone walls and the presence of the inflation channel for the balloon. The deflated balloon adds approximately 4Fr to the nominal tube size. Tube retention by an intact balloon is excellent but problems with displacement still exist due inadvertent balloon deflation or balloon rupture [56]. Low Profile ‘‘Button’’ Gastrostomy Tubes These are very short catheters with an external hub that just protrudes above skin level. It can be disconnected between meals, and due to its low profile the device is more aesthetically pleasing and harder for confused patients to remove. It does however require a higher level of dexterity to connect and disconnect the extension tubes. Button gastrostomies are available with a balloon or a mechanical retainer. The latter need less maintenance, but require significant oversizing of the track, making these difficult to insert and replace. Button gastrostomies were originally designed for placement in mature tracks, however de novo placement of balloon-retained button-type gastrostomies has been performed with a 98 % success rate [57]. Bumper-Retained Push- and Pull-Type PEG-Tubes Utilising the hybrid (PIG) technique allows placement of large calibre endoscopic type gastrostomy tubes made either of silicone or polyurethane. The push type catheters have a long tapered dilator, which is pushed through the mouth over the wire and through the gastrostomy track. Pull type catheters are pulled from the mouth into the gastrostomy track using a traction string that is passed from below. The traction string is designed to be retrieved endoscopically from the stomach after percutaneous insertion. Pull-PEGs are more difficult to place radiologically and wire-guided push-PEGs are preferable. Both push- and pull-PEGs are retained by mechanical bumpers. Semi-solid bumpers allow removal by forced traction under local anaesthesia. Tubes with rigid bumpers however require removal from the mouth, either endoscopically or after capture with a snare.

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Procedure Puncture sites are selected for the gastrostomy and gastropexies by placing radiopaque markers, such as artery forceps, along the costal margin to delineate them on fluoroscopy. Ideally the puncture sites should be to the left of the midline, from the mid-body to the antrum and equidistant from the lesser and greater curvatures to avoid the gastric and gastro-epiploic vessels. They should also be lateral to the rectus abdominis muscle in order to avoid the inferior epigastric vessels. A curved artery forceps at the planned puncture site easily confirms the ideal position on fluoroscopy. The puncture site and any planned gastropexy puncture sites are liberally infiltrated with lidocaine, taking care to anaesthetise the underlying peritoneum.

Radiologically Inserted Gastrostomy To fix the stomach for a RIG procedure, metal T-fasteners are then inserted into the distended stomach under fluoroscopic guidance using a needle attached to a syringe containing contrast media. The position is confirmed by aspirating air into the syringe and then injecting contrast under fluoroscopy and looking for the typical rugae of gastric mucosa. Once the T-fastener is deployed, the stomach is then apposed to the anterior abdominal wall and secured in position. Applying traction should be avoided, as tension subsequently increases with gastric deflation at the end of the procedure. A tight gastropexy is one of the commonest causes of post-procedure pain. Once gastropexy has been completed, a small skin incision is made between the sutures with a scalpel. An 18-gauge introducer needle attached to a syringe containing contrast media is then inserted through the incision and into the stomach and position again confirmed in the same manner as for gastropexy. The puncture should be in the anteroposterior plane, taking the shortest route across the peritoneum. If primary gastrojejunostomy is performed or future conversion anticipated, then directing the needle towards the pylorus is helpful. After the position is confirmed a stiff guidewire is inserted through the needle and coiled within the stomach. The puncture needle is then removed, and the track is dilated to a size 4Fr larger than the selected gastrostomy catheter. Dilation of the track can be performed using serial dilators or an angioplasty balloon. For balloon-retained devices, a peel-away sheath of 4Fr larger than the nominal tube size is used to support the introduction of the gastrostomy catheter into the stomach. Once inserted, the gastrostomy is secured by instilling the recommended volume of sterile water into the retention

balloon. Finally, the position is confirmed with contrast media injection under fluoroscopy.

Per-Oral Image-Guided Gastrostomy In cases where a more robust PEG tube is preferable, these can be placed non-endoscopically. For the hybrid (PIG) procedure, the stomach is insufflated with air and local anaesthesia applied as for RIG. Gastropexy is not required in this case. The puncture should be directed towards the fundus to facilitate oesophageal cannulation. Following insertion of a guidewire, a haemostatic vascular sheath is inserted into the stomach. A catheter and a hydrophilic guidewire are then used to cannulate the oesophagus retrogradely and the catheter advanced out through the mouth. In the case of a push-PEG, the hydrophilic wire is replaced with the 0.03500 exchange wire from the gastrostomy kit. The gastrostomy can then be inserted per-orally and advanced into place. At least one randomized trial supports the use of gastropexy for RIG, which has a number of proposed advantages. It fixes the anterior gastric wall during dilation of the track, it prevents intraperitoneal leakage of stomach contents prior to track maturation, and it can be helpful in resiting tubes should they become dislodged prior to track maturation [58]. Controversy exists about the number of gastropexy sutures required with considerable variation between groups. In their study, Shin et al. [59] reported a single anchor technique considered to be safe and effective, but others have demonstrated an increase in major complication rates, with a high rate of anchor dislodgement using this technique [60]. In their multicentre survey, Lowe et al. [20] showed that the majority of operators used two or three gastropexy sutures. If oesophageal access to the stomach is not possible, then gastric distension can be achieved by directly puncturing the stomach with a 21G needle under ultrasound or CT guidance, then directly insufflating through this [13]. Primary gastrojejunostomy is controversial. It is postulated that placement of the tip of the catheter in the jejunum reduces incidence of aspiration, and some advocate their placement in patients with a history of aspiration or reflux. Some groups have suggested the absence of clinically significant aspiration in their group is due to primary gastrojejunostomy placement [61], whilst others have demonstrated persistence of reflux despite gastrojejunal placement [62]. It is reasonable to consider conversion to gastrojejunostomy when there are large gastric residual volumes or recurrent aspiration. Conversion to gastrojejunostomy can also be performed to bypass a duodenal obstruction.

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The technique for primary radiological gastrojejunostomy is similar to primary gastrostomy, except that the gastric puncture is angled towards the pylorus. The pylorus is cannulated with a catheter and hydrophilic guidewire, the catheter is then advanced to the proximal jejunum and the wire exchanged for a stiff 0.03500 wire. The track is then dilated, and a gastrojejunal catheter placed. Conversion gastrojejunostomy may be performed at any time after gastrostomy placement if gastropexy is employed. If not, then the track should be allowed to mature (usually 4–6 weeks). Conversion to gastrojejunostomy utilises the existing gastrostomy track, and cannulation of the pylorus may be hampered by the angulation of the initial gastrostomy towards the fundus. Facial dilators and rigid or angled sheaths can be used to facilitate cannulation of the pylorus and track redirection [34]. Direct percutaneous jejunostomy was first described by Gray et al. [63] in 1987. The procedure may be required for patients whose stomachs are inaccessible or who have undergone gastrectomy. The procedure is complicated by the mobility of the small intestine, the small intestine’s compliance, the difficulty of maintaining it in a distended state and the proximity of vital non-targeted structures [64]. For these reasons, surgical jejunostomy using a Witzel tunnel is preferable to attempts at radiologic jejunostomy. Various techniques are described for identification and puncture of the target bowel. An angiographic catheter can be passed into the jejunum, which is then distended by instilling warm saline [37], and the distended jejunum is then punctured under US guidance, followed by placement of anchoring sutures [65, 66]. While little evidence exists to recommend the ideal number of anchoring sutures, care should be taken when anchoring the jejunum as it is more delicate than the stomach. CT can also be helpful to guide the puncture of the jejunum. Once cannulated, a small amount of contrast or air can be injected before rescanning to ensure intraluminal needle position [67]. Other techniques that include the placement of an angioplasty balloon or loop snare have been described [68]. After T-fastener placement a 0.03500 guidewire is passed and looped in the jejunum, followed by track dilatation and tube placement [11, 37]. Most groups describe the use of loop-retained catheters for percutaneous jejunostomy placement. Secondary jejunostomy is performed to re-establish a previously created surgical jejunostomy. The technique is similar to primary insertion, but T-fasteners may not be required due to surgical adhesions securing the loop to the abdominal wall.

Medication and Periprocedural Care Intravenous sedation and analgesia are commonly required for the procedure and a nurse trained in administering intravenous drugs and monitoring patients is necessary.

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Midazolam and fentanyl citrate are usually sufficient. Noninvasive monitoring equipment is essential and the patient’s heart rate, blood pressure and oxygen saturation must be monitored and recorded regularly during the procedure. Intraluminal distension is vital for the success of the procedure and antispasmodics such as hyoscine butylbromide or glucagon hydrochloride are useful, particularly in cases where it proves difficult to maintain gastric distension. One of the advantages of RIG is that it does not traverse the oropharynx and therefore does not expose the gastrostomy tube or track to the oral flora. Thus infective complications of RIG are rare, with a reported incidence of 2 % [69]. In a recent review of antibiotic prophylaxis in interventional radiology, Sutcliffe et al. [70] concluded that the routine use of antibiotic prophylaxis in percutaneous gastrostomy insertion does not reduce infection rates, and there is currently no evidence to support their use. Similarly, the use of methicillin-resistant staphylococcus aureus prophylaxis does not affect the rate of wound infection [20]. However, there is some evidence that prophylactic antibiotics may be useful in patients with head and neck cancer where infection rates can reach 15 % [71]. Cantwell et al. [71] suggested two regimens, which reduced infections rates among head and neck cancer patients to zero (p = 0.039): 1 g cephazolin IV at the time of the procedure followed by twice-daily cephalexin 500 mg for 5 days orally or via gastrostomy; or 600 mg clindamycin IV at the time of the procedure followed by twice-daily clindamycin 600 mg for 5 days orally or via gastrostomy. The use of prophylactic antibiotics has been shown to reduce infection rates in transorally placed hybrid gastrostomy insertion to levels comparable with pure percutaneous RIG insertion [9]. In patients undergoing PEG, the Endoscopy Committee of the British Society of Gastroenterology recommends a single dose of intravenous co-amoxiclav during the hour before the procedure except in patients already receiving broad-spectrum antibiotics who need no additional prophylaxis. In patients with penicillin allergy, they endorse teicoplanin [72].

Post Procedure Post-procedure imaging is usually not necessary; a correctly placed tube is easily rotated and advanced into the stomach. However if there is any doubt about intragastric placement then a limited unenhanced CT should be performed for clarification. Erect chest x-rays to exclude perforation are of no value as pneumoperitoneum is a natural consequence of puncturing a distended stomach and free subdiaphragmatic air must not be considered a reliable sign of bowel perforation. No consensus exists as to how soon feeding can be commenced after tube insertion. Most

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centres apply a 4–6 h period of fasting before testing the tube by injection of water. Prior to feeding the patient should be reviewed by a trained member of the nutritional support team to make a decision as to whether the tube can be used, clearly documenting the review and the decision in the notes. Of note a recent meta-analysis confirmed the safety of early feeding, even immediately, following PEG tube insertion [73]. Post procedure analgesia protocols should be in place to ensure pain is managed appropriately. Studies have demonstrated that peak pain occurs 6 h post gastrostomy, and at this time patients may still be drowsy from the sedation or are unable to communicate due to the underlying condition [74]. Patients may experience post-procedural discomfort or pain at the T-fastener site and may be associated with excoriation or ulceration [58]. Resolution usually occurs after removal of the T-fasteners, which have customarily stayed in for 7–14 days. Some have advocated removing T-fasteners as early as 2 days post procedure, demonstrating a reduction in post-procedural pain and superficial skin infections with no increase in complication rate [75]. Systems should be in place to ensure that the gastropexy sutures are released at an appropriate time. Enthusiasm for early removal of gastropexy sutures needs to be tempered by the risk of peritoneal displacement of the feeding tube in case of balloon failure. Gastrostomy tubes should be flushed after each use to prevent blockage and many manufacturers recommend warm water. It is important to check and adhere to the manufacturers instructions for use. Tube blockages are most commonly a consequence of instilling crushed tablets through the tube or the combination of chemically incompatible medications [76]. Flushing with saline or carbonated fluids may clear the blockage, but small syringes (2 ml or less) carry the risk of bursting the tube due to the high pressure generated. Failing that a guidewire can be inserted into the tube to try to relieve the obstruction. Ultimately it may be necessary to replace the gastrostomy. When exchanging gastrostomy catheters in an immature track a stiff wire can be inserted and an exchange made over the wire. In a situation where the gastrostomy is no longer in place or has dislodged, the track can be probed with a soft, hydrophilic wire or dilator to try and reestablish the existing track and allow gastrostomy replacement but should only be carried out by experienced operators, preferably with access to fluoroscopy.

Care of the Gastrostomy Site After 24 h, the tube should be cleaned daily with soap and warm water and kept dry. The tube should be rotated and pushed in and out every day to promote epithelialisation of

the track. Tubes must not be sutured in. A correct, snug fit of the external fixator is essential to apply the internal fixator to the gastric side of the stoma and prevent leakage of gastric content. Dressings around the tube should be avoided as they retain moisture and gastric acid and lead to skin excoriation and infection.

Outcomes Consistently high success rates for placement of RIG tubes are reported (95–100 %) [11, 13, 14]. In their meta-analysis, Wollman et al. [15] found rates of successful RIG placement to be 99.2 versus 95.7 % for PEG. RIG is also often successful where PEG has failed [11]. Rates of complication were also shown to be lower in the RIG group—5.9 versus 9.4 % for PEG; these were statistically significant for wound-related problems (major infection, septicaemia, wound dehiscence, etc.), aspiration and peritonitis [15], which has been confirmed in a more recent analysis [9]. High success rates have also been reported for de novo insertion of balloon-retained gastrostomy buttons [56] and radiological gastrostomies using push-PEGs [22, 77]. The success rate for primary gastrojejunostomy placement is also high ranging between 90 and 100 % [78, 79]. High success rates are also reported for conversion to gastrojejunostomy [61, 80]. Shin et al. [80] reported a 100 % success rate for placement of primary and conversion gastrojejunostomies. Technical success rates for direct percutaneous jejunostomy range between 85 and 90 % [66, 81, 82]. The main reported reasons for failure are difficulty in accessing the mobile jejunal loop. Endoscopic guided jejunostomy placement allows larger calibre, more secure mushroomtype tubes to be inserted, with resultant lower rates of tube dysfunction [69]. There is significant variation in the reported 30-day mortality rate, and early mortality is often due to the severe nature of the patients’ underlying illnesses. In their study, Bell et al. [61] reported a 30-day mortality rate of 17.1 %, with 71 deaths out of 416 treated patients, of which only two were procedure related. Other groups report similarly high 30-day mortality rates 11–14 %, but with a low incidence of procedure-related mortality [83, 84]. In a multicentre study, Laasch et al. [9] demonstrated an overall mortality rate of 1 % (5/643). Although these studies demonstrate significantly different overall 30-day mortality rates, they all demonstrate a low incidence of proceduralrelated mortality, and emphasise the importance of careful patient selection. In a prospective randomized trial, Thornton et al. [58] demonstrated that gastropexy placement reduces the risk of

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J. Sutcliffe et al.: Gastrostomy… Table 1 SIR classification system for complications by outcome [85].

Minor complications A. No therapy, no consequence B. Nominal therapy, no consequence; includes overnight admission for observation only Major complications C. Require therapy, minor hospitalisation (\48 h) D. Require major therapy, unplanned increase in level of care, prolonged hospitalisation ([48 h) E. Permanent adverse sequelae F. Death

intraperitoneal tube placement. Other cited advantages include rapid maturation of the gastrocutaneous track, reduced intraperitoneal leakage of gastric contents with peritonitis, and track access in case of inadvertent early tube removal. Catheter occlusion is a relatively common complication. Narrow calibre tubes have been shown to have a higher incidence of occlusion. Hoffer et al. [78] reported a 30-day occlusion rate of 13.6 % in 10F tubes versus 1.6 % in 22Fr tubes. De Beare’s group report a 30 day occlusion rate of 7.3 % using 16–18Fr catheters [13]. Lower occlusion rates are reported with the newer button catheters—Funaki’s group reported only one occlusion in 55 patients with mushroom retained catheters [22] and Lyons group reported no occlusion using balloon retained button catheters [17]. The small diameter and more complex configurations of gastrojejunostomy tubes, means they often require more frequent maintenance and replacement.

Complications Complications of percutaneous gastrostomy are classified as major and minor as defined by the Society of Interventional Radiology classification system for complications by outcome (Table 1) [85]. Table 2 shows the minor and major complications associated with percutaneous radiologic gastrostomy and their reported frequency [86]. Death due to procedure is reported as 0.3 % though this can be significantly higher in hospitalised patients [87] and patients with diabetes mellitus, poor nutritional status, or long-term corticosteroid administration [88].

Table 2 Minor and major complications associated with percutaneous radiologic gastrostomy and their reported frequency. Complications

Complications rate (%)

Minor complications Superficial peristomal infection

25–45

Leakage

11.4

Tube occlusion

4.5

Tube dislodgement

1.3–4.5

Major complications Haemorrhage Peritonitis

1.4 1.3

Death due to procedure

0.3

Colonic perforation

Minimal

Severe skin infection

Minimal

bacteria, fungi and yeasts. Skin swabs should always be taken for culture but are often negative. A range of topical creams combining antibiotics, antifungals and steroids are available, as well as non-specific agents including silver, hydrogen peroxide, potassium permanganate and woundhealing alginates. Infections can usually be managed on an outpatient basis. However, care should be taken that the infection does not progress to a severe infection with skin breakdown and sometimes, systemic antibiotics may be necessary. Management of infective complications can be very demanding and involvement of stoma specialists and dermatologists should be considered early. Overgranulation

Minor Complications

Overgranulation indicates an underlying problem, either of infection or mechanical irritation, and needs to be addressed prior to treatment with topical steroids and compression.

Superficial Peristomal Infection

Leakage

Incidence of superficial peristomal infections have been reported as high as 45 % in some series [89] but are rarely as a result of the procedure, rather as a result of poor wound hygiene after the procedure [12]. Organisms include

Leakage of enteral feed and gastric fluid at the gastrostomy site happens in 1.4 % of patients [86]. Risk factors for leakage include gastrostomy site infection, excessive cleansing with hydrogen peroxide, increased gastric acid

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secretion, buried bumper syndrome [90], excessive tension on the gastrostomy tube, and excessive lateral pressure on the tube usually when dressings are applied. The single anchor technique can also lead to pericatheter leakage by inducing considerable tension on the gastric wall adjacent to the track, causing ischaemic change in the gastric wall, which can in turn cause necrosis and ultimately enlargement of the gastrocutaneous track. [60]. If leakage occurs the site should be examined for infection, ulceration or a buried bumper and if the patient is not already on proton pump inhibitors these should be started [12]. If excessive lateral pressure is causing ulceration and enlargement of the track then securing the tube with a fixation device can be helpful [12]. Alternatively, exchanging for a thinner or softer tube can relieve the problem. Some authors have advocated using a larger-diameter tube but this is usually unsuccessful and can even exacerbate the problem of excessive lateral tension and resultant pressure on the stoma [91]. Exchanging for a gastrojejunostomy may also solve the problem by delivering the feed past the pylorus while at the same time decompressing the stomach. Once the cause has been addressed, attention should be given to wound care. Zinc oxide or stoma adhesive powder can deter local irritation. Alginate and foam dressings make a good alternative to gauze, as these can lift away the leaked fluid from the skin as opposed to gauze which may trap the fluid against the skin [12]. Leakage may also be secondary to fungal infections, and consideration should be given to topical antifungal agents. In intractable cases, it may be necessary to remove the tube altogether for a few days, sanitise the stoma with daily dressings of 1:10 000 potassium permanganate and allow the track to reduce in size before replacing the tube, or it may be necessary to re-site the gastrostomy. Specialist support from a dermatologist or a tissue-viability nurse should be sought in cases of progressive stomal retraction. Tube Occlusion Tube blockages are most commonly a consequence of particle obstruction from inadequately crushed tablets, precipitate formation following interaction between feed and drug formulations and precipitate formation following interactions between drugs [76]. Precipitation of enteral feed accounts for as much as 80 % of tube occlusions [92]. Administration of syrups, granular suspensions and enteric-coated medications are highly likely to cause tube occlusion. Enteric-coated tablets, such as esomeprazole and erythromycin, once crushed are prone to clumping within the tube. Crushing also destroys the protective coating meaning the drug’s bioavailability is unpredictable. Some capsules contain granules which may be either too

large or the suspension too viscous to pass through the tube, while some capsules may contain enteric-coated granules, such as lansoprazole, or granules with a modified release coating, such as slophylline, which are intended to be delivered intact, which again may occlude the tube [76]. In order to minimise the risk the tube should be flushed well with water or normal saline before and after each use to prevent enteral feed from blocking the lumen. When the lumen does occlude flushing the tube with normal saline may free the blockage in a third of patients [93]. Small syringes (2 ml or less) should be avoided as they carry the risk of bursting the tube due to the high pressure generated. If normal saline is ineffective. pancreatic enzymes have been shown to free blockages in a further 50 % [93]. If this fails, a guidewire passed through the tube to try to relieve the obstruction may be successful in which case consideration should be given to exchanging the tube. Sometimes, it may not be possible to remove the blockage in which case, the gastrostomy tube will need to be exchanged. Tube Dislodgement Dislodgement of the tube occurs in 1.3–4.5 % of gastrostomies but is more frequent in patients with altered mental status [12, 86]. If the tube does dislodge the track can be preserved by inserting a soft straight tube such as a Foley catheter into the track allowing time to arrange for formal replacement by an interventional radiologist, but this must not be used for feeding [94]. Care should also be taken when advancing the catheter and should be aborted if resistance is encountered. Formal replacement by an interventional radiologist usually involves an attempt at re-cannulation of the gastrostomy track but will depend on the age of the track and time elapsed since the tube was dislodged. Track maturation usually occurs within 7–10 days but may be delayed by up to 4 weeks in patients who have ascites, are malnourished or are on corticosteroid treatment [12]. Collares et al. [95] reviewed the management of 170 dislodged gastrostomies and gastrojejunostomies and found the reinsertion rate through the original track was 92 % on the first day of dislodgement, 91 % on the second day, 90 % on the third day and 71 % on or after the fourth day of accidental removal. However, mean indwell time for the tubes was 269.3 days (range 6–1898 days). If recognition of the dislodgement is delayed, then management involves nasogastric tube suction, broad-spectrum antibiotics and repeat gastrostomy in 7–10 days’ time [12]. Pain Complications of gastropexy insertion include pain, wound infection and balloon rupture. In their multicentre survey,

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Lowe et al. [20] demonstrated that gastropexy reduced the incidence of pain, but immediate post-procedure pain when present was more severe and increased with the number of gastropexy sutures used. If gastropexy sutures are fastened too tightly, then pain may be severe, particularly once gastric smooth muscle relaxants wear off and the stomach deflates. Major Complications Haemorrhage Haemorrhage during a RIG occurs in 1.4 % of patients [86] and major haemorrhage requiring transfusion in 1.2 % [96]. Risk factors for major haemorrhage include patients with peptic ulcer disease, oesophagitis, anticoagulation and previous anatomic alteration [86, 97]. Management usually involves assessment by endoscopy and, if possible, angiography, or both, with ligation, sclerotherapy or embolization if necessary. Peritonitis Peritonitis following a RIG occurs in 1.3 % of patients compared with 0.5 % after endoscopic placement [86]. It is generally caused by removal or dislodgement of the gastrostomy tube before the track matures, leakage from the stomach puncture site into the peritoneal cavity and perforation of the colon [86]. Mortality rate is high following peritonitis and so it is important to recognise and treat it early. A broad range of signs and symptoms are seen in peritonitis but common manifestations include abdominal tenderness or distension, rigors, fever, difficulty passing gas or having bowel movements and vomiting. Management involves broad-spectrum antibiotics and supportive care. Percutaneous drainage and/or surgical drainage may be necessary. Colonic Perforation The risk of perforating the bowel and, in particular, the colon is extremely low. Risk factors include inadequate insufflation of the stomach, thereby not displacing the colon sufficiently and causing poor visualisation of the transverse colon. If gastric distension is hard to maintain, then antispasmodics such as Hyoscine bromide and glucagon hydrochloride may be useful. A gastrostomy passing through the colon will ultimately lead to fistula formation and may involve the stomach, transverse colon and skin. Patients can present with colonic perforation, obstruction or peritonitis but are more likely to present with stool bypassing around the gastrostomy tube and diarrhoea which resembles the formula feed being used [12].

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Transcolonic placement may remain asymptomatic and discovered incidentally during a gastrostomy exchange when the replacement tube is advanced into the colon rather than the stomach, or it may be identified radiographically [12]. Management of this complication is usually conservative, simply allowing the fistula to close after the tube has been removed. Rarely, surgery may be required if the fistula fails to heal or peritonitis occurs. If colonic perforation is recognised at the time of the procedure, or prior to track maturation, then it should be understood that there is a risk of intraperitoneal leakage of gastric and colonic contents and hence peritonitis. One option is to leave the gastrostomy tube in situ and monitor the patient while the track matures and then manage conservatively. If this is not possible or desirable it nevertheless need not necessitate surgical management. Colonic perforation may result in a spectrum of illnesses, some of which may not result in clinically significant peritoneal contamination [98]. Whether patients have a high morbidity or mortality rate will depend on their existing medical conditions, the nature of the perforation, the method of management, the experience of the care team and the hospital setting [99]. In a review of colonic perforations following endoscopy, Lohsiriwat [99] states the 30-day morbidity and mortality rates are 21–53 and 0–26 %, respectively, and offers several factors for poor outcomes including a large perforation site, a delayed diagnosis, extensive peritoneal contamination, corticosteroid use, anticoagulant or antiplatelet therapy, prior hospitalisation, advanced age of patients and severe comorbid diseases. The choice between surgical and conservative management then will depend on clinical grounds. Conservative management should be reserved for those whose general condition is good and show no indication or peritonitis. Management involves intravenous fluids, complete bowel rest and intravenous administration of broad-spectrum antibiotics with patients expected to improve gradually within 24–48 h. Conservative management has been shown to have a success rate of between 33 and 73 % [99]. Operative management is reserved for those with diffuse peritonitis and patients in which non-operative management has led to clinical deterioration. A number of surgical options have been expounded such, as oversewing the perforation and bowel resection with or without intestinal continuity, for which endoscopic approaches are possible. Which surgical management option to choose would depend on the patient’s condition, the size of the perforation, any underlying bowel pathology, the time from injury to diagnosis and the available surgical expertise [99]. With advances in endoscopic technology, the possibility of endoscopic closure exists. This option would be dependent on having the appropriate endoscopic equipment and the skill of local endoscopists [99].

J. Sutcliffe et al.: Gastrostomy…

Severe Skin Infection Though minor skin infections are relatively common it is rare for them to progress to severe infections when appropriately managed. They are more likely to occur in patients who have had their gastrostomy sited via a transoral route, patients receiving immune-suppressant therapy and patients with diabetes mellitus, chronic renal failure, alcoholism or pulmonary tuberculosis [12]. If diagnosed early, broad-spectrum oral antibiotics are usually sufficient. However, if there are systemic signs of infection broadspectrum intravenous antibiotics in combination with specialist wound care are necessary. Necrotising fasciitis is a potentially lethal complication but is fortunately rare, particularly following RIG. Management should be aggressive and includes broad-spectrum intravenous antibiotics and early surgical debridement. In all cases, early involvement of a specialist stoma care team is essential.

Conclusions Radiological feeding tube insertion is a safe and effective procedure. Success rates are higher, and complication rates lower than PEG or surgical gastrostomy tube placement and innovative techniques for gastric and jejunal access mean that there are very few cases in which RIG is not possible. However, the key weaknesses of RIG are the relatively high occlusion rates due to the inherently smaller tubes required and the unreliable internal fixation. PIG attempts to address this but has not been taken up as a routine alternative to RIG or PEG and so its use will depend primarily on the local expertise. In the end, there is a need for robust randomised controlled trials evaluating PEG versus RIG placement for the delivery of enteral nutrition and this will guide any future evidence based guidelines. Consequently, in most institutions, PEG will remain the first line procedure when gastrostomy feeding is required while RIG is reserved for patients in which PEG has already failed and those who are too unwell or unsuitable for endoscopy, such as those with head, neck or oesophageal cancer. Patients undergoing gastrostomy have severe co-morbidities, reflected in reported post-procedural mortality rates, and it is vital that all patients are discussed in a multidisciplinary meeting to ensure appropriate patient selection. The interventional radiologist must be involved in pre-procedure patient assessment, ensure systems are in place for post procedure review by the interventional radiology team, and be available for management of any complication.

Compliance with Ethical Standards Conflict of interest None.

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