Hellenic Journal of Surgery (2018) 90:1, 16-21
O RIGINAL A R T I CL E
Staying the Surgeon’s Hand: Role of Percutaneous Catheter Drainage in Acute Necrotising Pancreatitis Dronacharya Routh, Naidu CS, Singh AK, Sanjay Sharma, Priya Ranjan
Abstract Introduction: Acute necrotising pancreatitis (NP) is associated with high morbidity and mortality. Patients with
infected pancreatic necrosis (IPN) require some form of intervention in addition to medical management. Although there is no accepted consensus, it is generally agreed that the infected non-vital solid tissue needs to be removed in order to control the sepsis. The results of early surgery have not been encouraging, compared with cases where surgery was delayed or avoided. The placement of percutaneous catheter drains in such a situation helps to decrease the systemic inflammatory response and reverse organ dysfunction. Aims and objectives: The aim of this study was to review retrospectively the results of percutaneous catheter drain-
age (PCD) in patients with acute NP requiring intervention. Materials and methods: A retrospective study was conducted of patients presenting with acute NP from March 2012 to June 2015. Demographic, clinical, and perioperative information was retrieved from the medical records. The patients were initially managed in the intensive care unit (ICU) with goal-directed therapy and organ support where indicated. The patients with IPN and few with sterile pancreatic necrosis (SPN) who had persistent organ failure or whose clinical condition was deteriorating despite adequate medical support were subjected to some form of intervention. All the patients requiring PCD or surgical intervention were included in this study. These patients were divided into 3 groups based on the type of intervention: a) PCD only, b) PCD followed by surgical intervention, and (c) surgery alone. The outcome in these 3 groups was analyzed and the factors associated with failure of PCD were identified. In addition, the complications of SPN were investigated. Results: The records were reviewed of 46 patients diagnosed with acute NP, of which 23 required PCD or surgical intervention and were included in this study. The mean acute physiology and chronic health (APACHE II) score of these patients was 10.6 ± 3.45, while the mean bedside index of severity in acute pancreatitis (BISAP) score was 4.47 ± 0. 53. On contrast enhanced computed tomography (CECT) scan of the abdomen, 39% of the patients had > 50% necrosis, with a mean CT severity index (CTSI) of 8.1 ± 1.9. Of the 21 patients treated initially with PCD, a step-up approach was applied in 8 patients, because of failure of PCD. The mean duration from admission to intervention was 19.5 days. A mean of 2.4 pigtail catheters were placed in each patient. Additional drains were placed in 3 patients. The duration of PCD ranged from 20 to 124 days. The mean ICU stay was 14.3 ± 3.2 days and the mean hospital stay was 35.8 ± 7.4 days. Post-intervention complications were recorded in 11 (47.8%) patients, of which 2 patients with PCD developed an external pancreatic fistula and 2 had bleeding. The mortality rate was 26% (6 patients). Conclusion: PCD is a feasible and successful modality of treatment for acute NP requiring intervention. With the use of PCD, surgical necrosectomy may be completely avoided or delayed until the condition of the patient is stable enough to sustain surgery. Key words: Necrotising pancreatitis; step-up approach; percutaneous catheter drainage
Introduction Dronacharya Routh, Naidu CS Singh AK, Sanjay Sharma, Priya Ranjan Faculty of Surgical Gastroenterology. Corresponding author: Dr. Dronacharya Routh Reader/Instructor, Department of Surgery, Armed Forces Medical College, Pune 411010 Tel.: +919464667808, e-mail:
[email protected] Received Jan 12, 2018; Accepted Feb 23, 2018
Hellenic Journal of Surgery 90
Around 10% to 20% of patients with acute pancreatitis develop severe disease, which is characterized by intrapancreatic or peripancreatic necrosis [1-6]. Necrotizing pancreatitis (NP) is the most severe form of acute pancreatitis and it is associated with high morbidity and mortality due to the development of infected pancreatic necrosis (IPN), and multisystem organ failure. The mortality rate of acute
Staying the Surgeon’s Hand: Role of Percutaneous Catheter Drainage in Acute Necrotising Pancreatitis 17
NP ranges from 10% to 40%, and it is especially high (up to 50%) when the necrosis is infected and progresses to sepsis and multi-organ failure [1-3,7,8]. The subset of patients with IPN and a small proportion of those with sterile pancreatic necrosis (SPN) require some form of intervention in addition to medical management. There has been much debate, but to no consensus has been reached on the optimal management in this group. It is generally agreed that the infected non-vital solid tissue needs to be removed in order to control the sepsis. For many decades open surgical necrosectomy (ON) was the gold standard treatment for IPN [2,3,7,8]. The results, however, were poor, and the prognosis of immediate ON was worse than when surgery was delayed or avoided [9-13]. It has been postulated that the metabolic impact of ON in an already critically ill patient exceeds the physiological reserves of the patient, resulting in high morbidity and mortality, and that ‘staying the surgeon’s hand’ will allow the maturation of the necrotic tissue and improvement of the patient’s condition. Application of percutaneous catheter drainage (PCD) in this situation will ‘take the heat out of the fire’ by relieving the pus/fluid under pressure, decreasing the systemic inflammatory response and reversing organ dysfunction [14-19].
Aims and objectives The aim of this study was to review retrospectively the results of PCD in patients with acute NP, and to analyze the factors associated with failure of PCD and the complications of PCD in sterile pancreatic necrosis (SPN).
Materials and methods A retrospective study was made of the demographic, clinical, and perioperative details of patients admitted to a tertiary care hospital with acute NP from March 2012 to June 2014. The records were reviewed of 46 patients diagnosed with IPN, who were initially managed by the gastroenterology unit. All the patients were treated in the intensive care unit (ICU) with goal-directed therapy, including fluid replacement, early enteral nutrition, broad spectrum antibiotics (carbapenems) and organ support where indicated. The patients with IPN diagnosed on contrast enhanced computed tomography (CECT) of the abdomen with gas within the necrosis, and by blood culture positive for sepsis, and a few patients with SPN who had persistent organ failure, abdominal compartment syndrome or deteriorating clinical condition despite adequate medical support were selected for some form of intervention. The 23 patients who required PCD or surgical intervention were included in this study. These patients were divided into 3 groups according Hellenic Journal of Surgery 90
to the type of intervention: a) PCD only, b) PCD followed by surgical intervention, and c) surgery alone. The outcome in these 3 groups was analyzed and the factors associated with failure of PCD were identified. Percutaneous catheter drainage
For drainage, 12-18Fr pigtail catheters were placed under ultrasound (US) guidance by a radiologist. Multiple catheters were placed where indicated. The catheters were flushed regularly with normal saline once or twice daily to prevent clogging. Additional drains were placed or existing drains were replaced in the case of development of new foci of ongoing sepsis. The drains were removed when there was clinical improvement of the sepsis, drain output was minimal, there were no new or residual foci, and the drain fluid amylase was normal. Step-up approach
Following PCD, a few patients had to undergo open surgical drainage as a step-up approach, under the following conditions: a) inability to drain all fluid/necrotic material due to poor access or difficult locations, b) persistent organ failure despite drainage, and c) complications of PCD, such as hemorrhage, perforation or obstruction. Open drainage
A few patients with persistent organ failure and deteriorating clinical condition without any drainable collection were treated by direct surgery. This group of patients underwent ON. The necrotic tissue was drained internally into the stomach via the posterior wall. Exclusion Criteria
The patients with pancreatic abscess or with late complications (>6weeks) following acute pancreatitis were excluded from the study.
Statistical Analysis The data were presented as numbers (%) or mean ± SD / median (range) as appropriate. All demographic, pre-operative, intraoperative and post-operative continuous variables were subjected to univariate analysis using the Student t-test, or the Wilcoxon Mann Whitney Test if the data were not normally distributed. All categorical variables were compared between groups using the Chi-square test or Fischer’s exact test, as appropriate. A p value of <0.05 was considered statistically significant. All statistical analysis was performed using Stata 9.0 (College Station, Texas, USA).
18 Dronacharya Routh, et al
Results The pre-intervention demographic and clinical profile of the 23 patients in the study population is shown in Table 1. All of the patients had persistent organ failure. The mean acute physiology and chronic health (APACHE) II score was 10.6 ± 3.45 while the mean bedside index of severity in acute pancreatitis (BISAP) score was 4.47 ± 0. 53. On CECT of the abdomen, 39% of the patients had > 50% necrosis with a mean CT severity index (CTSI) of 8.1 ± 1.9. Of the 23 patients with PN who underwent intervention, 18 had proven IPN and 5 had SPN (Table 2). A total of 21 (91.3%) of the patients underwent PCD while the remaining 2 patients were treated by ON with no prior drainage.
Table 1. The demographic and clinical profile of patients with necrotizing pancreatitis (n=23). Characteristics
Numbers
Age
38.4 ± 14.3 years
Male:Female
21:2
Etiology Alcohol
12 (52%)
Gallstone disease
7 (30%)
Idiopathic
3 (13%)
Other causes
1 (5%)
Persistent organ failure
19 (100%)
Ranson’s score (0-11)
Discussion
7.4 ± 0.8
BISAP score (0-5)
4.47 ± 0.53
APACHE II score
10.6 ± 3.45
CTSI score
8.1 ± 1.9
Pancreatic Necrosis < 30%
3 (13%)
30-50%
11 (48%)
>50%
9 (39%)
BISAP: Bedside index of severity in acute pancreatitis APACHE: Acute physiology and chronic health CTSI: Computed tomography severity index
Table 2: Distribution of study population of patients with necrotizing pancreatitis, based on type of necrosis and intervention (n=23). Type of intervention PCD
IPN (n=18)
SPN (n=5)
10
3
Upfront Surgery
2
0
PCD followed by surgery
6
2
IPN: Infected pancreatic necrosis, SPN: sterile pancreatic necrosis PCD: percutaneous catheter drainage
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Of the 21 patients treated by PCD a step-up approach was applied in 8 patients, because of failure of PCD. The mean duration from admission to intervention was 19.5 days. A mean of 2.4 pigtail catheters were placed in each patient, and additional drains were placed in 3 patients. The duration of PCD ranged from 20 to 124 days. The mean ICU stay was 14.3 ± 3.2 days and the mean hospital stay was 35.8 ± 7.4 days. With PCD, surgery was successfully avoided in 12/23 (52.2%) patients with PN. On analysing the factors associated with failure of PCD, in 8 patients, statistical significance was demonstrated for the BISAP score (p<0.01), the APACHE II score (p<0.003), extensive intra-pancreatic necrosis of > 50% (p<0.046) and an increased CTSI (p<0.015) (Table 3). Complications in the study population are shown in Table 4. Of the 23 patients, 11 (47.8%) presented post intervention complications; 2 patients with PCD developed an external pancreatic fistula (drain fluid amylase 3 times the upper normal for serum), and 2 presented bleeding. The mortality rate was 26% (6 patients). Although the numbers were small, rate of complications in the surgery alone group was significantly higher than in the PCD group or the step-up-approach group (Table 4). We also attempted to evaluate the complications in the patients with SPN who underwent interventions (Table 5), 2 of whom had complications, but the difference was not significant when compared with the IPN group.
ON in the initial period of acute pancreatitis is considered detrimental and is generally avoided. Surgeons often need to intervene, however, during the first few weeks due to IPN, or even in some cases of SPN with deterioration of the clinical condition (such as increasing abdominal hypertension) and persistent organ failure. In such a situation primary PCD can obviate the need for surgery in a significant proportion of patients [17, 20]. In the landmark PANTER trial, surgery was avoided in 35% of patients by PCD [17]. In the present study, surgery was not needed for 52% patients. In a systematic review and meta-analysis by VP Mouli and colleagues, pooled analysis of 12 retrospective studies including a total of 481 patients revealed that surgery was avoided in 64% of patients who were treated by PCD [21]. PCD can also be used as a bridging procedure to stabilize critically ill patients temporarily, until they are in a condition suitable for a definitive operative procedure [20, 22 and 23]. In the present study, 8 patients underwent ON following PCD, of which half had reversal of organ failure with PCD, but and were taken for surgery because of persistence of a significant amount of necrotic tissue.
Staying the Surgeon’s Hand: Role of Percutaneous Catheter Drainage in Acute Necrotising Pancreatitis 19
Table 3. Factors associated with successful and failed percutaneous catheter drainage (PCD) in study population (n=23). Variables
Successful PCD (12)
Failed PCD (9)
p value
40.4 ± 8.7
37.9 ± 10.5
0.24
11:1
8:1
0.57
12 (100%)
9 (100%)
0.99
Ranson’s score
7.8 ± 1.2
8.3 ± 0.6
0.08
BISAP score
3.38 ± 0.2
4.79 ± 0.1
0.01
APACHE II score
8.6 ± 2.8
12.6 ± 2.3
0.003
> 50% necrosis
2 (16.7%)
7(77.8%)
0.046
CTSI score
6.9 ± 1.8
8.7 ± 0.6
0.015
10 (83.3%)
6 (75%)
0.76
Age Male:Female Persistent organ failure
Infected pancreatic necrosis
BISAP: Bedside index of severity in acute pancreatitis, APACHE: Acute physiology and chronic health, CTSI: Computed tomography severity index
Table 4. Complications in patients with pancreatic necrosis (n=23). Variables
PCD Alone (13)
Step-Up-Approach (8)
Surgery Alone (2)
p value
External pancreatic fistula
2 (15%)
0
0
-
Intra-abdominal bleed
2 (15%)
0
2 (100%)
0.002
Upper GI bleed
0
1(12.5%)
0
-
Pseudocyst
0
2 (25%)
0
-
Multiorgan failure
1 (7.7%)
3 (37.5%)
2 (100%)
0.001
Mortality
1 (7.7%)
3 (37.5%)
2 (100%)
0.004
PCD: percutaneous catheter drainage
Table 5. Complications in infected pancreatic necrosis (IPN) and sterile pancreatic necrosis (SPN). Complications
IPN (18)
SPN (5)
p value
External pancreatic fistula
1 (5.56%)
1 (20%)
0.45
Intra abdominal bleed
1 (5.56%)
1 (20%)
0.44
Upper GI bleed
1 (5.56%)
0
0.32
Pseudocyst
1 (5.56%)
1 (20%)
0.44
Multiorgan failure
3 (16.67%)
1 (20%)
0.78
Mortality
3 (16.67%)
1 (20%)
0.78
Of the 18 patients who had IPN, 10 (83%) were managed with PCD alone, along with antimicrobial therapy and supportive care. Conventionally, according to earlier studies, surgical debridement and drainage had been the treatment of choice in this group [17]. It can therefore be said that in a select group of patients with IPN non-surgical intervention such as PCD can be applied safely, with comparable outcome. PCD appears to be technically feasible in the vast majority of patients with acute NP [18, 20]. One Hellenic Journal of Surgery 90
of the advantages of this method is that several catheters may be placed simultaneously in different pancreatic and peripancreatic regions to drain the liquefied necrosis, without general anesthesia and with less trauma than ON. Although PCD is a feasible option for the management of acute NP, it is important to know that in some of these patients it is likely to fail, and surgical intervention will subsequently be required. In an attempt to analyse the factors involved in the success of the method, we showed that high BISAP, APACHE II and CTSI scores were associated with failure of PCD. Extensive necrosis (> 50%), which was detected in 7 of the patients, was also associated with failure of PCD. Several authors consider that surgical resection of the necrotic tissue is mandatory at the beginning of the disease, as catheter drainage of infected solid necrotic tissue is poor [7-10, 24-26], but others have shown that solid tissue and necrotic debris can be evacuated from the cavities by the application of vigorous irrigation through large-bore catheters [15-19]. We used pigtail catheters of various widths, ranging from 12-18 Fr, for drainage of the necrotic tissue. We compared the rate of complications in the 3 study groups. A systemic review of 11 studies, with a total of 384 patients undergoing PCD, conducted by van Baal MC and
20 Dronacharya Routh, et al
colleagues in 2011, reported an overall rate of complications of 37.8%, consisting mainly of external and internal pancreatic fistula. The overall mortality rate was 17·4 % (67 of 384 patients) [20]. In our series of 21 patients who underwent primary PCD, 9 (42.8%) patients presented complications, and there were 4 deaths (19.1%), but the numbers are too small for valid comparison. There is lack of agreement on the indications for intervention in SPN. The argument in favor of draining sterile collections was supported by the Wistar rat model study, in which 60 rats were randomized to no intervention, ON and PCD. The levels of inflammatory cytokines were higher in the no intervention group than in the PCD group [27]. Wang and colleagues reported a study of PCD in 452 patients, of whom 248 had SPN. Surgery was avoided in 91% of the patients and there was a mortality of 10.9% [28]. Although the numbers in our study were small we managed to avoid surgery in 60% of our patients with SPN, with a 20% mortality.
Conclusion This study has shown that PCD is a feasible and successful modality of treatment for acute NP requiring intervention. By the application of PCD, surgical ON may be either completely avoided or delayed until the patient is in a stable enough condition to sustain surgery. It is important to recognize in advance the subset of patients who will probably require ON at a later date.
5. 6.
7. 8.
9.
10.
11.
12.
13.
14.
Conflict of Interest: The authors declare that they have no conflict of interest. Ethical Approval:The study was performed in a manner to conform with the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning Human and Animal Rights, and the authors followed the policy concerning Informed Consent as shown on Springer.com
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