Surg Endosc DOI 10.1007/s00464-014-3961-4
and Other Interventional Techniques
Outcome of conservative percutaneous cholecystostomy in high-risk patients with acute cholecystitis and risk factors leading to surgery Won Seok Jang • Jun Uk Lim • Kwang Ro Joo • Jae Myung Cha • Hyun Phil Shin • Sun Hyung Joo
Received: 12 February 2014 / Accepted: 21 October 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Laparoscopic cholecystectomy (LC) is the treatment of choice for acute cholecystitis. However, the morbidity and mortality rates are high in elderly patients or in those with co-morbidities at the time of surgery. Percutaneous cholecystostomy (PC) is a safe treatment for acute inflammation of the gall bladder. This study aimed to evaluate the safety and efficacy of PC for acute cholecystitis and investigate the post-PC factors leading to subsequent LC. Materials and methods Ninety-three patients with acute cholecystitis who underwent PC between August 2006 and December 2012 were retrospectively reviewed for clinical course, outcomes, and prognosis. We evaluated patient age, the presence of co-morbidities, American Society of Anesthesiologists (ASA) score, duration of drainage of the PC tube, performance of LC, conversion rate, hospital stay, recurrence, and 30-day mortality. We compared these characteristics in two study groups: 31 were treated with
only conservative PC (group I) and 62 with PC followed by elective LC (group II). Results Patients in group I were older than those in group II (80.38 ± 10.05 vs. 70.50 ± 11.81 years, p \ 0.001). More group I patients had an ASA score of III or IV (deemed high risk for surgery) compared to group II patients (80.6 %, n = 25 vs. 37.0 %, n = 23, p = 0.0012). Age, ASA score, and cerebrovascular accident (CVA) were significantly correlated when analyzing factors used to decide surgery (R2 = 0.15, p \ 0.001; R2 = 0.21, p \ 0.001; R2 = 0.05, p = 0.05, respectively). Two patients in group I died within 30 days. Six patients (19.3 %) in group I experienced recurrent cholecystitis after PC tube removal. Conclusions PC is a safe and effective therapeutic option in high-risk patients with acute cholecystitis, or for preoperative management. The decisive risk factors for surgery after PC were age, ASA score, and CVA.
Won Seok Jang and Jun Uk Lim have contributed equally to this work.
Laparoscopic cholecystectomy (LC) is the standard treatment for most patients with acute cholecystitis. Advantages of LC over open cholecystectomy include less pain, smaller scars, shorter hospital stay, and faster mobilization [1]. However, in the high-risk elderly and patients with significant co-morbidities for surgery, acute cholecystitis can develop into more critical illnesses with atypical courses and higher mortality. Furthermore, the conversion rate to open cholecystectomy and perioperative complications increase in high-risk patients when performing LC [2–12]. Percutaneous cholecystostomy (PC) effectively decompresses the biliary system drainage via a cholecystostomy catheter and ameliorates symptoms in a relatively short
W. S. Jang J. U. Lim K. R. Joo (&) J. M. Cha H. P. Shin Department of Gastroenterology, Kyung Hee University Hospital at Gangdong, School of Medicine, Kyung Hee University, 892 Dongnam-ro, Gangdong-gu, Seoul 134-727, Korea e-mail:
[email protected] W. S. Jang e-mail:
[email protected] S. H. Joo Department of Gastrointestinal Surgery, Kyung Hee University Hospital at Gangdong, School of Medicine, Kyung Hee University, Seoul, Korea
Keywords Cholecystitis, acute Cholecystostomy, percutaneous Cholecystectomy, laparoscopic
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time with only local anesthesia required. Therefore, PC can either be used to control acute cholecystitis as a definitive management for septic patients or for those with severe comorbidities associated with a higher risk for performing emergency cholecystectomy, or used as a bridge to surgery. Elective LC after preoperative PC can decrease the conversion rate to open cholecystectomy compared with emergency LC without PC [2, 5, 8, 10]. Furthermore, conservative PC can be an alternative management for many high-risk patients who do not undergo cholecystectomy, as old age and the presence of co-morbidities are expected to increase morbidity and mortality after elective LC [4–6]. This study aimed to evaluate the safety and efficacy of PC, analyze clinical outcomes of PC in high-risk patients, and determine the factors used to choose surgery in patients with acute cholecystitis after PC.
Materials and methods We retrospectively analyzed 116 patients who underwent PC, with or without cholecystectomy, for acute cholecystitis in the Kyung Hee University Hospital at Gang dong, Seoul, Korea from August 2006 to December 2012. Twenty-three patients were excluded as they had cholecystitis caused by malignancy, common bile duct stones, or pancreatic disease. Ninety-three patients who were included in the study had pain in the right upper quadrant, a positive Murphy sign, or signs of systemic inflammation (fever [38 °C or infection markers such as increased C-reactive protein or white blood cell count). Diagnosis was confirmed through an ultrasound or computed tomography (CT) scan of the abdomen that showed a thickened gallbladder wall [13]. Patients meeting any of the following criteria were performed PC without emergent LC and were included in the study: (1) systemic inflammatory response syndrome (SIRS) manifests by two or more of the following conditions: a temperature [38 °C or \36 °C, an heart rate [90 beats/min, a respiratory rate [20 breaths/min or a PaCO2 \32 mmHg, a white blood cell count [12,000/mm3 or \4,000/mm3; (2) co-morbidities such as CVA, chronic renal failure (CRF); (3) inadequate ASA score; or (4) need immediate intensive care unit (ICU) care. Conservative therapy (fasting, intravenous infusion, and antibiotic treatment) was started immediately after acute cholecystitis was diagnosed. Patient characteristics including age, sex, the presence of co-morbidities, and American Society of Anesthesiologists (ASA) score were documented. Laboratory data measured on admission included liver function tests and white blood cell counts. The ASA classification was used to preoperatively assess physical status for anesthetic risk [14]. We reviewed the
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complications related to PC, time until symptoms improved after PC, and duration of the drainage of the PC tube in all patients. We investigated patients who did not undergo cholecystectomy for recurrence of biliary events and complications after PC tube removal. In patients who underwent cholecystectomy, any perioperative complications were also recorded. PC was performed by an interventional radiologist who used ultrasound guidance under local anesthesia with 1 % lidocaine. A 21-gage Chiba needle was introduced transhepatically into the gallbladder. After placement of a guidewire and sequential dilation of the track, a 7-Fr pigtail catheter was positioned with its tip in the gallbladder. Bile was aspirated from most patients for a cholangiogram performed immediately after tube placement to confirm the pigtail catheter was at the correct position in the gallbladder. The PC catheter was left open, connected to a collection bag, flushed daily with a saline solution, and drained by gravity. The PC was considered successful when clinical improvement was observed with a decrease or disappearance of pain and fever as well as lack of complications related to PC. All LC procedures were performed by one experienced general surgeon who used the conventional four-port technique. The PC catheter was removed at the beginning of the operation. In patients treated with conservative PC without surgery, the drainage tube was removed when the patients showed no symptoms of recurrence (such as fever or abdominal pain) after the PC tube had been clamped. Continuous variables were presented as the mean ± standard deviation. Student’s t test, non-paired t-test, or v2 test were used to compare the means between both groups. A simple linear regression analysis was applied to study the factors used to determine surgery, including age, ASA score, the presence of co-morbidities, and clinical laboratory data. Multivariate logistic regression was also used to determine dependent variables related with operation in univariate analysis. A p value \ 0.05 was considered significant. All statistical analyses were performed using the SPSS program (SPSS 18.0, SPSS Inc, Chicago, IL, USA).
Results Baseline patient characteristics and clinical patterns Among the 93 study patients, 31 patients underwent conservative PC without cholecystectomy (group I) and 62 patients underwent preoperative PC followed by elective LC (group II). The mean follow-up period was 350.50 ± 393.02 days. The mean age of all patients was
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73.80 ± 12.14 years; the mean age of the patients in group I was higher than those in group II (80.38 ± 10.05 vs. 70.50 ± 11.81, p = 0.0012). The female-to-male ratio was 1:1.27 with no significant difference between both groups (1:1.38 vs. 1:1.21). No significant difference was found between both groups in terms of mean duration of pain before admission, the presence of high temperature on admission, mean leukocyte count, and liver function tests. The ratio of patients with gallstones to those without gallstones was lower in group I than group II (58.0 vs. 83.8 %, p = 0.004). Cerebrovascular accident (CVA) was more frequently a co-morbidity in group I than group II (45.1 vs. 20.9 %, p = 0.049). No significant difference was found in other co-morbidities between both groups. The mean proportion of surgically high-risk patients with ASA
III or IV was higher in group I than group II (80.6 vs. 37.0 %, p = 0.0012). Twenty-three patients (24.7 %) were admitted in the ICU, but no significant difference was found in admittance between both groups. CCI score was higher in group I than group II (5.61 ± 1.43 vs. 4.55 ± 1.56, p = 0.005) (Table 1). On univariate analysis, the factors leading to surgery significantly correlated with age, ASA score, CVA and CCI score (R2 = 0.15, p \ 0.001; R2 = 0.21, p \ 0.001; R2 = 0.05, p = 0.05; R2 = 0.188, p = 0.005). In multivariate regression analysis with significant variables in univariate analysis, age and ASA score were associated with surgery (odds ratio = 1.12, 95 % confidence interval = 1.05–1.19, p \ 0.001; odds ratio = 5.14, 95 % confidence interval = 2.15–12.31, p \ 0.001).
Table 1 Clinical characteristics of patients in both groups Total (n = 93)
Group I (n = 31)
Group II (n = 62)
p value
Age (years)
73.80 ± 12.14
80.38 ± 10.05
70.50 ± 11.81
\0.001
Sex (male/female)
41/52
13/18
28/34
NS
Clinical characteristics Onset pain (days)a
2.95 ± 3.82
3.03 ± 3.49
2.90 ± 4.04
NS
4 (4.3)
2 (6.4)
2 (3.2)
NS
Fever, n (%)b Laboratory tests WBC (/mm3)
14194.62 ± 5524.66
13096.77 ± 6563.81
14743.55 ± 4891.36
NS
CRP (mg/dL)
15.20 ± 10.71
14.58 ± 10.53
15.52 ± 10.87
NS
Bil. T (mg/dL)
1.30 ± 1.01
1.24 ± 1.11
1.32 ± 0.97
NS
Alk-P (IU/L)
359.89 ± 261.36
386.88 ± 341.99
346.62 ± 213.05
NS
Gallstone, n (%)
70 (75.2)
18 (58.0)
52 (83.8)
0.004
DM, n (%)
39 (41.9)
13 (41.9)
26 (41.9)
NS
HTN, n (%)
61 (65.5)
20 (64.5)
41 (66.1)
NS
CVA, n (%)
27 (29.0)
14 (45.1)
13 (20.9)
0.049
CRF, n (%)
6 (6.4)
2 (6.4)
4 (6.4)
NS
I
12 (12.9)
2 (6.4)
10 (16.1)
II III
33 (35.4) 30 (32.3)
4 (12.9) 11 (35.4)
29 (46.7) 19 (30.6)
IV
Co-morbidities
\0.001
ASA score, n (%)
18 (19.4)
14 (45.1)
4 (6.4)
CCI score
5.08 ± 1.49
5.61 ± 1.43
4.55 ± 1.56
p = 0.005
ICU care, n (%)
23 (24.7)
7 (22.5)
16 (25)
NS
SIRS, n (%)c
18 (78.2)
4 (57.1)
14 (87.5)
NS
Group I: conservative PC Group II: bridge PC followed by operation WBC white blood cell, CRP C-reactive protein, Bil. T total bilirubin, Alk-P alkaline phosphatase, DM diabetes mellitus, HTN hypertension, CVA cerebrovascular accident, CRF chronic renal failure, ASA American Society of Anesthesiologists Score, SIRS Systemic inflammatory response syndrome, CCI Charlson co-morbidity index a
Duration of pain before admission
b
Body temperature [38 °C
c
Among patients in ICU
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Surg Endosc Table 2 Comparison of the clinical outcomes of both groups after percutaneous cholecystostomy Group I (n = 31)
Group II (n = 62)
p value
The period of symptomsa improvement (days)
3.15 ± 3.029
2.12 ± 1.274
NS
Duration of drainage of the PC tube (days)
69.52 ± 133.67
9.68 ± 6.45
Duration of hospital stay (days)
27.28 ± 25.07
17.48 ± 11.78
No recurrence (n = 25)
Recurrence (n = 6)
p value
80.46 ± 10.05
81.0 ± 10.32
NS
9/25 (36) 17/25 (72)
4/6 (66.7) 3/6 (50)
NS NS
CVA, n (%)
10/25 (40)
4/6 (66.7)
NS
CRF, n (%)
1/25 (4)
1/6 (16.7)
NS
ASA score (I/II/III/ IV), n
2/3/9/11
0/1/2/3
NS
Calculous, n (%)
14/25 (64)
6/6 (100)
\0.001
Age (years) Co-morbidities
Procedure-related complication, n (%)
1 (3.2)
1 (1.6)
Recurrence, n (%)b
6 (19)
0 (0)
DM, n (%) Hypertension, n (%)
\0.001 0.049 0.500 \0.001
a
Right upper quadrant pain, positive Murphy’s sign and/or fever (°C)
b
Recurrence of acute cholecystitis after PC tube removal
Comparison of clinical outcomes between both groups Two patients died after PC of acute cholecystitis-induced sepsis. However, for 91 patients, symptoms improved during a mean time of 2.95 days, which was not significantly different between groups I and II (3.15 ± 3.03 vs. 2.12 ± 1.27 days). No procedure-related complications were reported in those who had PC, except for one patient in each group with bile leakage on the same day as PC (3.2 vs. 1.6 %, p = 0.500). The drainage of PC tube was for longer in group I than those of group II (69.52 ± 133.67 vs. 9.68 ± 6.45 days, p \ 0.001). Higher CRP was associated with the drainage duration of the PC tube only in group I (R2 = 0.14, p = 0.04). Group I had longer hospital stays than group II (27.28 ± 25.07 vs. 17.54 ± 11.43 days, p \ 0.05). In both the groups, age, laboratory data, comorbidities, and the drainage duration of PC tube were not associated with duration of hospital stay (Table 2). Six patients in group I experienced recurrent cholecystitis after PC tube removal. Two patients in group II underwent conversion to open cholecystectomy with no postoperative complications reported. Outcomes of conservative PC and recurrent cholecystitis in group I In group I, 6 patients (19 %) experienced recurrence of acute cholecystitis during the mean follow-up period of 194.93 days (range 27–905 days). Age, ASA score, and comorbidities were not significantly different between the recurrence and no recurrence groups. However, patients in the recurrence group were more likely to have gallstones than those in the no recurrence groups (6/6, 100 % vs. 14/25, 64 %, p \ 0.001) (Table 3). Recurrent cholecystitis was related to the presence of gallstones (R2 = 0.17,
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Table 3 Comparison between no recurrence and recurrence patients in group I
DM diabetes mellitus, CVA cerebrovascular accident, CRF chronic renal failure, ASA American Society of Anesthesiologists Score
Table 4 Specific characteristics for patients with recurrent acute cholecystitis in group I Sex
Age (years)
ASA score
Duration of drainage of the PC tube(days)
Recurrence interval (days)a
Management
1
F
96
2
165
905
Supportive care
2
F
76
4
19
29
Conservative PC
3
M
67
3
29
35
Operation
4
M
86
4
12
112
Conservative PC
5
F
86
3
11
61
Conservative PC
6
M
75
3
9
27
Supportive care
a
Time until recurrent acute cholecystitis after PC tube removal
p = 0.02). Three of the six patients with recurrent cholecystitis underwent repeat PC; one had surgery with informed consent and the last two underwent conservative management with intravenous administration of fluids and broad-spectrum antibiotics (Table 4).
Discussion LC is the curative treatment of choice in patients with acute cholecystitis. However, in elderly patients with co-morbidities, emergency LC can result in serious morbidity and mortality [2, 7, 8, 10]. PC is an alternative surgical treatment for these high-risk patients because it can reduce acute inflammation with decompression of gallbladder by rapidly
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draining bile under local anesthesia, although it is not currently the standard treatment [2–12]. No prospective controlled studies have compared the outcomes of PC versus LC in high-risk patients with acute cholecystitis. However, highrisk patients are more likely to be treated with PC than LC [2– 12]. In previous studies of the safety of PC, procedure-related complications were only 3–6.25 %, which is relatively low considering candidates are usually high-risk patients [4–6, 9]. In our study, we found procedure-related complications were only 2.2 %, which is comparable with previous reports. Therefore, PC is a safe treatment option in patients with acute cholecystitis deemed unfit for surgery. Factors that determine whether surgery should be performed in high-risk patients include complicated acute cholecystitis, old age, and the presence of co-morbidities such as hypertension and diabetes mellitus [15]. The Charlson co-morbidity index (CCI) was developed to predict 1-year mortality for surgically treated patients and is frequently used to estimate the patient’s general condition. Some variables included are the presence of congestive heart failure, peripheral vascular disease, myocardial infarction, CVA, and diabetes mellitus [16]. Anderson et al. [11] reported that the mean CCI score and prediction of 1-year mortality were significantly higher in the PC group than those in the cholecystectomy group. This study showed that patients in the PC group were likely to be older and have more co-morbidities than the cholecystectomy group. In our study, the CCI score was also significantly higher in group I patients who underwent conservative PC than in group II who underwent LC with elective PC. There are several reports that old age and co-morbidities are principal factors to increase morbidity as well as mortality after cholecystectomy [1–4]. Therefore, such patients were decided to undergo PC without LC in our study. The use of PC for acute cholecystitis is increasing, but large-scale studies on the most appropriate timing of LC after PC have yet to be performed and variable outcomes for this measure are seen in several reports. Han et al. [8] reported no conversions to open cholecystectomy when the LC was performed within 3 days of PC. However, conversion was observed in 6.5 % of patients who underwent LC more than 3 days after PC. Kim et al. [2] showed that the conversion to open surgery was performed in 2.6 % of patients who underwent LC more than 7 days after PC, whereas it was 14.3 % for those who underwent LC within 7 days after PC. Conversely, Chikamori et al. [7] reported that conversions occurred in 33 % of patients who underwent LC more than 7 days after PC for acute cholecystitis, while only 3 % of patients underwent LC within 7 days after PC. Therefore, a suitable maintenance period for PC tube before opting for elective LC has not been established. Our study showed that the LC was performed at a mean of 9.68 days after PC and 3.2 % of patients experienced
conversion to open cholecystectomy, which was relatively low compared with several other reports. During a mean 6-month follow-up period, cholecystitis recurred in 6/31 patients (19 %) treated only with conservative PC without operation. Sugiyama et al. [5] reported that 33 % of patients after conservative PC experienced recurrent cholecystitis during a mean 1.8-year follow-up period. All patients with recurrent cholecystitis also had gallstones, similar to those in our study. Several previous reports also showed that gallstones were related to recurrent cholecystitis after PC tube removal and can be one of the factors causing recurrence [4–6, 9]. Hence, acute cholecystitis with gallstones may not be completely cured by performing PC. Patients with gallstones are vulnerable to recurrent cholecystitis after PC catheter removal. In summary, PC can be a safe and effective therapeutic alternative to LC in high-risk patients such as the elderly and patients with co-morbidities. Factors that indicate a need for conservative PC were identified as old age, CVA as co-morbidity, and a higher ASA score. Conservative PC without cholecystectomy is associated with a higher rate of recurrence in acute calculous cholecystitis when compared with the acalculous variety. Therefore, if possible, we suggest performing cholecystectomy in cases of acute cholecystitis with gallstones. Disclosures Won Seok Jang, Jun Uk Lim, Kwang Ro Joo, Jae Myung Cha, Hyun Phil Shin, and Sun Hyung Joo have no conflicts of interest or financial ties to disclose
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