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© 2016 EDIZIONI MINERVA MEDICA Online version at http://www.minervamedica.it
Minerva Chirurgica 2016 December;71(6):415-26
REVIEW
Timing of percutaneous cholecystostomy tube removal: systematic review Daniele MACCHINI 1, Luca DEGRATE 2, Massimo OLDANI 1, Davide LENI 3, Pietro PADALINO 2, Fabrizio ROMANO 1, Luca GIANOTTI 1* 1School
of Medicine and Surgery, University of Milano-Bicocca, S. Gerardo Hospital, Monza, Italy; 2Department of Surgery, S. Gerardo Hospital, Monza, Italy; 3Department of Radiology, S. Gerardo Hospital, Monza, Italy *Corresponding author: Luca Gianotti, Department of Surgery, S. Gerardo Hospital - 4° Piano, settore A, Via Pergolesi 33, 20900 Monza, Italy. E-mail:
[email protected]
A B S T RA C T INTRODUCTION: Percutaneous cholecystostomy (PC) is an effective procedure to treat moderate or severe acute cholecystitis (AC) in high-risk patients. The ideal timing of the drainage removal is argued. The aim of this study is to analyze our experience and perform a systematic review about the ideal timing of a percutaneous cholecystostomy (PC) tube removal. EVIDENCE ACQUISITION: A web-based literature search was performed and studies reporting the length of the catheter maintenance were analyzed. A regression analysis between the timing of tube removal and morbidity, mortality and disease recurrence was performed. Patients who underwent PC as definitive treatment of moderate or severe acute cholecystitis at our institution between 2011 to 2015 were analyzed. Clinical and technical success, morbidity, mortality and recurrence rates were retrospectively retrieved from a perspective database. EVIDENCE SYNTHESIS: The systematic review yield to analyze 50 studies. None of them focused exclusively on outcome measures in relation to PC tube duration. The timing of the drain removal varied from 2 to 193 days. Regression analyses showed no correlation between length of tube maintenance and the considered outcomes. We studied 35 patients. The median age was 78 (range 52-94) and 88.5% had an ASA score ≥3. P-POSSUM estimated morbidity was 68.7% (range 34.3-99.0) and mortality was 15.8% (range 1.9-80.2). Clinical success was 97.1%. Procedure-related morbidity was 34.3%: 2 abscess, 1 bleeding, 1 biloma and 8 tube dislodgment. Biliary leakage was not observed. The observed 30-day overall mortality was 11.4%. The median follow-up was 16 months. Recurrence rate was 12.1%. CONCLUSIONS: PC is an effective procedure in high-risk patients with moderate or severe AC. At the moment there is no evidence whether the duration of PC tube may affect outcome. (Cite this article as: Macchini D, Degrate L, Oldani M, Leni D, Padalino P, Romano F, et al. Timing of percutaneous cholecystostomy tube removal: systematic review. Minerva Chir 2016;71:415-26) Key words: Cholecystostomy - Cholecystitis, acute - Catheters.
Introduction
E
arly cholecystectomy (EC), performed within one week from symptom onset, is the recommended treatment of acute cholecystitis (AC).1-3 Yet, the procedure may be associated with high morbidity (20-30%) and mortality rates (6-30%) in high-risk patients,4-7 such as elderly subjects, carrying severe co-
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morbidities, with rapidly deteriorating clinical conditions, and progressive severe biliary sepsis. In these cases, conservative management by antibiotic therapy and supportive care may be a treatment option although there is the risk of disease progression toward empyema, gangrene, perforation, and abscess formation.8, 9 Surgical cholecystostomy, introduced by Bobbs 10 in 1859, was the only available meth-
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TIMING OF PERCUTANEOUS CHOLECYSTOSTOMY TUBE REMOVAL
od for gallbladder decompression for more than a century. Than, percutaneous cholecystostomy (PC) was first described in 1921 as a radiological exam and introduced for therapeutic purposes in 1979 by Radder.11 Nowadays, cholecystostomy is considered an accessory and useful procedure to treat sepsis of biliary origin 5, 12, 13 but no definitive recommendations has be yet produced on the outcome of PC versus early cholecystectomy because randomized clinical trials are lacking.14, 15 Furthermore there are still several disputed issues on the PC management. For example, the ideal timing of the PC indwell tube removal is argued since the available data are often controversial. Several authors retrospectively analyzed their personal results on the outcome of PC, but often the length of the tube indwelling was not reported. Wise et al.16 were the first to analyze the biliary leakage rate related to the catheter management. They reported a higher incidence of biliary leak in the group of patients in whom cholangiogram was not performed before removing the tube, but this group had also their tube dislodged inadvertently. Furthermore in this study there was no data on the number of patients who had the drainage placed by the trans-hepatic or a trans-peritoneal route which may affect biliary leakage rate. The aim of this study was to evaluate, based on our experience and a systematic review of the literature, if the duration of the PC tube stay was a possible determinant of outcome in moderate or severe AC in high-risk patients in term of recurrence, morbidity, and mortality rates. Evidence acquisition An extended literature web search was performed using MEDLINE, Embase, PubMed, Scopus, Web of Science, and the Cochrane Library Medline, for studies published between the year 2000 and 2015. The following medical subjects search headings terms and all their possible combinations were used: “cholecystostomy”, “gallbladder ”, “percutaneous”, “drainage”, “ drain”, “tube”, “catheter”, “timing”, “duration”, “length”, “removal”. The
416
“related articles” function and the references list of the studies retrieved for full-text review were used to broaden the search. Study inclusion criteria for this review were the description of outcomes related to cholecystostomy and the reporting of the length of the catheter maintenance. We collected information on the number of included patients, rate of clinical success, operated patients, length of the follow up, timing of the tube removal, morbidity, dislodgement, mortality, recurrence rates. Regression lines were obtained by plotting the occurrence rates of the outcome parameters against the timing of tube removal and an R2 value >0.5 was considered significant. Since most of the previous studies did not compare groups based on the length of catheter in place, a formal meta-analysis could not be performed. Starting from 2011 the data of all patients admitted at our institution with AC were prospectively collected in an electronic database. The diagnosis of AC was based on the Tokyo guidelines:2 physical examination (right upper quadrant abdominal pain and tenderness), laboratory tests (white blood cell count and C-reactive protein elevation), and ultrasonographic findings (gallbladder enlargement with wall thickness >3 mm, gallstones, sludge, pericholecystic fluid, ultrasonographic Murphy’s sign). After the diagnosis of AC was made, antibiotic therapy (Piperacillin/tazobactam as first choice), intravenous fluid replacement, and proton pump inhibitors were administered in all our patients. From this database, we retrospectively selected all PC procedures done as definitive treatment for AC regardless the presence of gallstones or choledochal lithiasis up to 2015. Despite there were no specific internal protocols, all cases were discussed among senior surgeons and the decision to perform a PC as a definitive treatment of AC was based on the criteria described in Table I. Data retrieved from the database were: age, gender, body mass index, severity of AC, presence of sepsis or septic shock at admission,20 presence of gallstones, presence of active can-
Minerva Chirurgica
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©
TIMING OF PERCUTANEOUS CHOLECYSTOSTOMY TUBE REMOVAL MACCHINI
Identification
Table I.—Criteria for definitive PC. –– Moderate AC with ASA≥3 –– Severe AC (any ASA) –– Rapid progression of biliary sepsis
Records identified through database searching (N.=3756)
AND any of
cer, American Society of Anesthesiologists (ASA) score,17 estimated morbidity and mortality based on P-Possum,18 Sepsis-related Organ Failure Assessment (SOFA) score,21 timing of PC tube removal, hospital stay, disease recurrence rate, actual 30-day morbidity rate, 30-day and 1-year mortality rates. The severity of complications was scored according to the Clavien-Dindo 22 classification. Clinical success of PC was defined as relief of signs and symptoms, and a decrease of body temperature, C-reactive protein and white cell count within 72 hours, while technical success was defined as the ultrasound demonstration of the correct PC tube placement into the gallbladder lumen.23 Blood culture was performed at admission. Follow-up was performed by telephone interviews or planned office visits. PC technique All PCs were performed in the interventional radiology unit by a dedicated and trained radiologist under ultrasonographic guidance. The gallbladder fundus was visualized by the ultrasound probe and accessed by the transhepatic approach. After placing a guidewire (Amplatz Super Stiff Guide Wire, Boston Scientific Corp, Natick, MA, USA) and sequentially dilating the track, a 8 F pigtail catheter (HS, Aprilia, Latina, Italy) was introduced into the gallbladder. Bile samples were taken for anaerobic and aerobic cultures. The catheter was secured to the abdominal wall with 2-0 silk sutures at the puncture site and allowed to drain by gravity. Cholangiography was not performed rou-
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Screening
AC: acute cholecystitis; ASA: American Society of Anesthesiologists; P-POSSUM: Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity. *(based on the Italian Statistics Institute mortality tables).
Records removed (duplicates) (N.=731)
Records screened (N.=3025)
Records excluded because not relevant for our purpose (N.=2939)
Eligibility
–– P-POSSUM-based estimation of high morbidity/mortality –– Advanced neoplasia –– Short-life expectancy*
Additional records identified through other sources (N.=0)
Full-text articles assessed for eligibility (N.=86)
Full-text articles excluded, because not reporting the timimg of PC tube removal (N.=36)
Included
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Studies included in the systematic review (N.=50)
Figure 1.—PRISMA flow diagram.
tinely before the catheter removal. The PC tube was removed 24 hours after the bile supply ended. Evidence synthesis The PRISMA flow diagram is reported in Figure 1. After excluding from the initial identified records (N.=4256) the duplicated ones (N.=1231) and those not relevant for our review (N.=2939), 86 papers reporting data on the management and outcome of cholecystostomy were identified. Among these, we selected 50 studies reporting the length of the catheter maintenance (Table II).22-70 The studies included in the present review were very heterogeneous. The number of patients in the reports ranged from 3 to 278 patients. Most of the authors opted for the transhepatic approach, but also the transperitoneal route was frequently used.24, 30, 34, 35, 50 Clinical success ranged from 27% to 100%. The PC tube was removed after 1 to 427 days, with a dislodgement rate of 0% to 34.8%. Overall morbidity was reported in a range of 0% to
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TIMING OF PERCUTANEOUS CHOLECYSTOSTOMY TUBE REMOVAL
Table II.—Systematic review of the literature. Author, year
N° of patients
Access
Berber 2000 24
13
87%
82(49-154)
Pessaux 2000 25 Andrèn-Sandberg 2001 26 Chopra 2001 27
27 86 21
TP: 62% TH: 38% NR NR TH
89% 81% 95%
3.4% 8.1% 14%
Granlund 2001 28
51
39.2%
4%
25%
Berman 2002 29 Hatzidakis 2002 30
10 60
0% 5%
55 45 80
2% 13% 2.5%
16% 2.2% NR
Akinci 2004 34
37
86%
(3-25) >14 for TH >21 for TP > 60 54.3 (1-357) < 180 (40%) 45± 180 (16%) 180 or more (11%). 14 (2-60)
10% 1.7%
Spira 2002 31 Byrne 2003 32 Hadas-Halpern 2003 33
TH: 92% TP: 8% TH TH: 57% TP: 43% TH >TH TH
20 (9-60) 4.28 42 15.2 (4-31)
6% 4.7% 6.1% 3.7% 0% 3.7% 10.4%
0% 3.1% 15.2% 13.6% 0% 29.6% NR
Howard 2009 42 Koebrugge 2010 43
3 35
32.7 (28-42) 28 (2-171)
0% 2.9%
0% 14.3%
Gumus 2011 44
14
31.7 (28.41)
0%
0%
Nasim 2011 12
62
92%
60 (2-90)
31%
NR
91% 100% 93% NR 81.8% 96.3%
7 (3-21) 23 (14-34) 51 (15-71) 16.6±14 21-28 19 (5-57)
8.7% 6.7% 0% 6% 18.2% 25.9%
4.3% 3.3% 0% 10.2% 9.1% 33.3%
NR NR
47 (3-120) 43 (28-114)
NR 13%
NR 1.9%
70.4% 27% 66.7%
12.4 (8-14) > 42 44±17
31% 4.3% 71.4%
NR 34.8% 9.5%
91%
49 (2-169)
6%
42% 97.5% 95%
48.5 34.6±44.6 22.9±15.8
12% 2.4% 3.3%
Melloul 2011 45 Carrafiello 2012 46 Chung 2012 47 Hsieh 2012 48 Kapan 2012 49 Kortram 2011 50
23 30 57 166 11 27
McGillicuddy 2012 51 Sanjay 2012 52
67 53
Rodrìguez-Sanjuan 2012 53 Chok 2013 54 Gunay 2013 55
27 23 21
Nikfarjam 2013 56
32
Smith 2013 57 Cha 2014 58 Chang 2014 59
418
143 47 60
TH: 86.5% TP: 13.5% TH: 72% TP: 20% NR: 8% TH TH NR TH TH TH TH: 87.5% TP: 12.5% TH TH: 91% TP: 9% TH: 85.7% TP: 14.3% TP: 35% TH: 21% NR: 44% TH TH>TP NR TH TH TH: 7.4% TP: 92.6% TH TH:71.6% TP:28.4% TH TH TH: 76.2% TP: 23.8% TH: 25% TP: 75% TH TH TH: 98% TP: 2%
Clinical success Catheter removal (days) Morbidity *
80% 86.7% 95.7% 80% 85%
67% 90.1% NR NR 92.6% 90.7% 85.4% 100% 94% 78.6%
Minerva Chirurgica
13%
Dislodged
13% NR 5% NR
12% 7% NR 11.7%
December 2016
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Biliary mortality
Procedure related mortality
Recurrence
Elective surgery
Urgent surgery **
Follow-up (months)
13%
7.7%
0%
7.7%
92.3%
0%
16.7 (0.5-53)
7.4% 7% 14%
3.7% 1% 5%
0% 6% 0%
7.4% 47% 4.8%
7.4% 9% 18%
11% 2.3% NR
17 (4-40) 6 178.7(1-22)
16%
0%
0%
55%
55%
4%
35 (0-113)
10% 17.5%
0% 6%
10% NR
0% 1.7%
20% 14%
1 11.6%
NR NR
5% 20% 15%
5% 2% 3%
0% 0% 0%
NR 2.2% 0%
55% 7% 40%
4% 17% NA
13.5 (1-42) NR 12
21.6%
8.3%
0%
NR
16.7%
50%
NR
20%
4%
0%
12%
40%
8%
20.2 (6.7-40.2)
17% 13.8% NR NR 4% 3.7% 6.3%
6% 2% NR NR 4% 3.7% 4.2%
0% 0% 0% 0% 0% 0% 0%
17% NR 13.6% 0% 9.3% 36%
0% 3% 27.3% 18% 0% 51.9% 33.3%
6% 9% 1.5% 0% 25% 5.6% 0%
NR 20.4 (4-56) NR 11 (6-18) NR 4-36 17.2
0% 8.6%
0% 2.9%
0% 0%
33.3% 0%
0% 66%
33.3% 5.7%
12 24 (3-66)
21.4%
21.4%
0%
7.1%
NR
21.4%
13.3 (4-21)
15%
NR
NR
9.67%
32.3%
4.8%
12 (4-72)
13% 0% 19.3% 15.1% 18.2% 14.8%
0% 0% 7% 9% 0% 0%
0% 0% 0% 1.2% 0% 3.7%
14.8% 0% 7% 8.7% NR 19.7%
82% NR 32% 31.9% 45.5% 14.8%
8% NR NR 0.6% 18% NR
16 (2-44) NR 32 (15-72) 25.4 NR 2
22.4% 22.6%
NR NR
NR 1.96%
0% 22%
65.7% 11.3%
NR 7.5%
30 30 (1.77-112)
17.2% 17.4% 33.3%
7.4% NR 19%
3.7% 4.3% 0%
7.4% 4.3% 33.3%
3.5% 34.8% 33.3%
29.6% 4.3% 19%
14.6 (1-57) 35 20.4±16
9%
0%
0%
48%
28%
NR
43
4.2% NR 0%
0% 0% 0%
NR 0% 11.6%
41% 0% 5%
1.4% 0% NR
30.5 4.1 (0.1-51.5) 38.1±24.8
Overall mortality
11.9% NR 0%
(To be continued)
Vol. 71 - No. 6
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TIMING OF PERCUTANEOUS CHOLECYSTOSTOMY TUBE REMOVAL
literature (continues). Table II.—Systematic review of the literature. Author, year
N° of patients
Flexer 2014 60 Jang 2014 61 Karakayali 2014 62 Khasawneh 2015 63 Leveau 2014 64
25 93 43 245 35
Suzuki 2015 65 Atar 2014 66 Yao 2014 67 Zerem 2014 *** 68
82 71 29 36
Kirkegard 2015 69
56
Horn 2015 70
278
Viste 2015 71 Current study
104 35
Access
Clinical success Catheter removal (days) Morbidity *
NR TH TH NR TH: 75% TP: 25% NR TH TH TH: 14% TP: 86% TH: 19.6% TP: 76.8% NR: 3.6% TH: 22.3% TP: 73% NR:4.7% TH TH
Dislodged
NR NR 93% NR 74.3%
25 29.6 NR 55 (42-75) 14
NR 2.2% 4.7% NR 37.7%
NR NR NR NR 8.6%
NR 97.5% 100% 100%
49 3 (0.75-8) 8.1±1.4 15 (12-20)
NR 1% 5.6% 22%
NR 5% 0% 19%
NR
10
26.8%
25%
NR
11.5 (0-193)
7.2%
28.6%
97.2% 97.1%
6.5 (1-75) 9 (2-28)
4.8% 11.4%
7.6% 22.9%
TH: transhepatic; TP: transperitoneal; NR: Not Reported; *: Morbidity= dislodgement excluded; **: Delayed cholecystectomy due to recurrent disease or cholecystectomy within same admission; ***: Calculous AC (timing of catheter removal not reported for acalculous AC).
71.4%, while overall, biliary and procedure-related mortality were in ranges of 0% to 33.3%, 0-21.4% and 0% to 10% respectively. Recurrence rate varied from 0% to 55%. Most of the trials did not specify if the PC was proposed as a definitive treatment and the percentage of patients who underwent surgery varied from 0% to 100% for late elective operation and from 0% to 50% for early cholecystectomy. Figure 2 depicts the correlation analyses between, overall mortality (A), biliary mortality (B), overall morbidity (C), disease recurrence rate (D) and the time of the catheter removal. Regression lines showed no clear advantages when the percentage of occurrence of the above outcome parameters were plotted against the length of drainage in place. During the study period in our center, 262 patients were admitted with AC, 37 of which underwent PC as definitive treatment. Two patients who had a coexisting acute biliary pancreatitis were excluded because PC was only part of a most complex therapeutic pathway. Table III shows the characteristics of the 35 patients included in the analysis. Patients had an advanced age (median 78) and elevated ASA score (≥3) was reported in 88.5%. The
420
median P-Possum estimated morbidity was 68.7% (range 34.3-99%) and mortality 15.8% (range 1.9-80.2%). The median SOFA score was 4 (range 1-13). Severe AC was diagnosed in 31.4% of the cases and AC was sustained by stones in 85.7% of the cases. Biliary and blood cultures are summarized in Table IV. Blood cultures were performed in 27 subjects (77.1%) and found positive in 44.4% (12/27) while bile culture was obtained in 32 cases (91.4%) and positive results were observed in 23/32 patients (71.9%). The most frequent isolate was E. coli in the blood while in the bile, E. coli and Enterococcus spp were predominant. We recorded only two cases of extended-spectrum β-lactamases (ESBL) producer E. coli. Table V describes the outcomes. The technical and clinical success rates were 100% and 97.1% respectively. PC catheter was left in place for a median of 9 days (range 2-28). Ten patients (28.6%) required intensive care admission during hospitalization, for multiorgan failure, with a median stay of 2 days (range 1-30). The median hospital stay was 21 days (range 6-49). The procedure-related morbidity was 34.3% (12/35): 2 abscesses (both grade 3 according
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Overall mortality
Biliary mortality
Procedure related mortality
Recurrence
Elective surgery
Urgent surgery **
Follow-up (months)
4% 2.2% NR 17.6% 15%
0% 2.2% 0% NR 2.9%
0% 0% 0% 0% 0%
24% 6.5% 0% NR 11.4%
52% 66.7% 100% 29% 2.9%
NR 0% 0% NR 2.9%
35 11.7±13.1 23 (7-29) 6.1 (1.7-19.4) 60
5% 18.5% 0% 19%
NR 18.5% 0% 2.8%
NR 0% 0% 0%
NR NR 0% NR
34% 78% 100% 16.7%
35.4% 2.5% 0% 5.6%
NR 4 (0.75-36) NR 13 (5-24)
10.7%
NR
NR
14.3%
19.6%
7.1%
NR
4.7%
NR
NR
23.5%
21.8%
10.1%
60 (13.2-126)
3.8% 11.4%
1.9% 8.6%
0% 0%
NR 12.1%
28.8% 0
NR 1
12 (0-78) 16 (1-48)
A
B
C
D
Figure 2.—Correlation analyses between overall mortality (A), biliary mortality (B), overall morbidity (C), disease recurrence rate (D) and the time of the catheter removal.
to Clavien-Dindo), 1 bleeding (grade 2) and 1 biloma (grade 2). Tube dislodgment was observed in 8 patients, 4 of which required reinsertion. Biliary leakage was not observed.
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Thirty-day overall mortality was 11.4%: 3 cases for septic shock (2 of biliary origin and 1 of pulmonary origin) and 1 for advanced cancer.
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TIMING OF PERCUTANEOUS CHOLECYSTOSTOMY TUBE REMOVAL
Table III.—Baseline characteristics of the studied cohort (N.=35). Median (range) or N. (%)
Age, years Sex Male Female Body mass index Advanced neoplasia Acute cholecystitis grade Moderate Severe Sepsis at admission Septic shock at admission Alithiasic Lithiasic ASA 1 2 3 4 Estimated P-POSSUM morbidity Estimated P-POSSUM mortality SOFA Time from admission to PC (days)
78 (52-94) 22 (62.9) 13 (37.1) 24 (18-29) 8 (22.9) 26 (74.3) 9 (25.7) 35 (100) 5 (14.3) 5 (14.3) 30 (85.7) 4 (11.4) 20 (57.1) 11 (31.4) 68.7% (34.3-99) 15.8% (1.9-80.2) 4 (1-13) 3 (0-14)
ASA: American Society of Anesthesiologists; P-POSSUM: Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity; SOFA: Sepsis-related Organ Failure Assessment; PC: percutaneous cholecystostomy.
Four of 33 patients (12.1%) needed hospital readmission for recurrent biliary disease (all within 6 months): 2 for moderate AC (1 treated by open cholecystectomy and 1 by PC), 1 for mild acute pancreatitis due to a papillary stenosis, and 1 for a biliary tract lithiasis. The two cases of recurrent AC were sustained by stones, while in patients with pancreatitis or main biliary tract lithiasis, the US revealed gallbladder sludge. The median follow-up was 16 months (range 1-48). Discussion International guidelines suggest PC as an appropriate treatment of AC, but with divergences in patient population and with different aims. The Tokyo guidelines 2 suggests to consider PC in moderate AC if the gallbladder is markedly inflamed and for patients who do not respond appropriately to conservative therapy,
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Table IV.—Blood and bile cultures. Blood culture
Not performed Negative E. coli –– ESBL+ K. pneumoniae –– KPC+ Enterococcus spp. –– faecalis –– faecium –– avium –– hirae Streptococcus spp. C. perfringens Bacteroides spp. Lactobacillus spp.
Bile culture
8/35 (22.9%) 15/27 (55.6%) 9/27 (33.3%) 0/27 (0%) 2/27 (7.4%) 0/27 (0%) 1/27 (3.7%) 0/27 (0%) 1/27 (3.7%) 0/27 (0%) 0/27 (0%) 1/27 (3.7%) 1/27 (3.7%) 0/27 (0%) 0/27 (0%)
3/35 (8.6%) 9/32 (28.1%) 10/32 (31.3%) 2/32 (6.2%) 3/32 (9.4%) 0/32 (0%) 10/32 (31.3%) 4/32 (12.5%) 5/32 (15.6%) 1/32 (3.1%) 1/32 (3.1%) 4/32 (12.5%) 0/32 (0%) 1/32 (3.1%) 1/32 (3.1%)
ESBL: extended-spectrum β-lactamases; KPC: Klebsiella pneumoniae carbapenemase.
Table V.—Outcome parameters (35 patients). Median (range) or N. (%)
Clinical success Technical success Catheter in place, days Overall morbidity In-hospital mortality Septic shock Advanced neoplasia Hospital stay, days 1- year overall mortality Advanced neoplasia Acute renal failure Unknown* Recurrence Moderate acute cholecystitis Mild acute pancreatitis Biliary tract lithiasis Follow-up, months
34 (97.1) 35 (100) 9 (2-28) 12 (34.3) 4 (11.4) 3 (8.6) 1 (2.8) 21 (6-49) 8 (22.9) 3 (8.6) 1 (2.8) 4 (11.4) 4/33 (12.1) 2 (6.1) 1 (3) 1 (3) 16 (1-48)
*Patients with no information at the end of the follow-up but reported deceased at the local registry office.
while urgent drainage or cholecystectomy in case of severe AC. The Society of American Gastrointestinal and Endoscopic Surgeons recommends radiologically-guided PC in critically ill patients with acute cholecystitis, as an effective temporizing measure until the patient recovers sufficiently to undergo cholecystectomy.72 The outcome after PC seem to be similar in patients with calculous or acalculous AC 56 and nearly a third of the patients require subsequent definitive treatment by cholecystectomy.54 The
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data from our series did not allowed a separate outcome analysis on alithiasic vs. lithiasic AC for the small number of patients. Up to now only case series and retrospective analysis are available to compare early cholecystectomy to PC in different populations and disease severity. Moreover, there are no suggestions on the potential role of PC as a definitive treatment in patients with prohibitive anesthesiology risk or with a short life expectancy for concomitant incurable diseases or severe comorbidities.14 Karakayali et al. reported that in patients with AC, admitted within 72 hours after symptom onset and not responding to nonoperative treatment for 48 hours, transhepatic PC with delayed cholecystectomy produced better outcomes and fewer complications than emergency laparoscopic cholecystectomy.62 Instead, Smith et al. reported higher mortality associated with PC when compared with cholecystectomy 57 but in their study the two groups of patients seem to have substantial differences in term of severity of AC. The results of Hatzidakis et al. suggested that PC should not be the treatment of choice in highrisk patients, since it did not reduce mortality. They proposed selective PC in patients not improving after 3 days of conservative treatment, critically ill, and candidates for percutaneous lithotripsy.30 Also in other reports PC failed to reduce morbidity rates and a significant longer hospital stay was observed when PC was compared with early cholecystectomy.73 Furthermore, patients who underwent PC were more likely to have conversion to open surgery or intraoperative complications than non-PC patients.60 It should not be neglected that PC has per se specific procedure morbidity occurring immediately or within days such as biliary peritonitis, intestinal perforation, sepsis, pneumothorax, catheter dislodgment 75, 76 and late complications such disease recurrence.77, 78 A direct comparisons among the trials included in this systematic review was impracticable for the heterogeneity of cases and the indications to PC. This may reflect the lack of
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clear recommendations and indications in international guidelines 2 on when and to whom PC should be performed as a bridge to surgery or as definitive treatment. In most of the studies the latter was the preferred approach and only in 16 papers.24, 28, 40, 41, 43, 45, 48, 49, 51, 55, 60-62, 65-67 PC was used mainly as a bridge-to-surgery. In the present review we observed also a wide range of disease recurrence rate. This may be related to a different rate of cholecystectomy performed, since only surgery can avoid disease recurrence. The optimal duration of the PC indwelling tube and its role on limiting procedure-related complications or disease recurrence has never been analyzed and risks and benefits of an early catheter removal are largely controversial. From the analysis of previous trials it seems that the choice on the timing of tube removal was mainly based on subjective clinical thinking and pathophysiological argues rather than on hard evidences. Some authors stated that the ideal maintenance time was until the consolidation of a cysto-cutaneous fistula.30 This process is probably necessary only for the transperitoneal approach, in order to avoid bile leak. In fact, Hatzidakis et al.30 in their series removed the tube later in patients who undergo transperitoneal PC compared to those who has a transhepatic approach (21 vs. 14 days). Other authors focused their attention on the risk of disease recurrence and the catheter was removed only after a cholangiogram showing a cystic duct patency and a well-tolerated temporary clamping,78 or the tube was maintained in place until elective delayed cholecystectomy.62 In our institution, as in other centers,26, 29, 34, 39, 41, 45, 53, 64, 66-71 the PC catheter was removed after a short period of time if compared to the vast majority of previous reports. The safety of this early timing may be attributed to the transhepatic approach not needing the maturation of a fistula. Also, this strategy does not seem to increase the rate of morbidity, mortality and recurrence of biliary disease as compared with the finding of other studies. We are confident that this assumption may be reliable since also our regression anal-
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yses showed no correlation between the considered outcomes and the length of the catheter kept in place. Yet, we are not advocating a standardized or generalized early removal time of the tube. A “good clinical nous” advises to left in place the catheter until improvement or resolution of the scenario and to tailor the duration on the single patient need. Nonetheless, preconceived long tube maintenance does not seem to be justified. Despite in our institution there were no predefined criteria, indication for PC was mainly given for patients with an elevated anesthesiologic risk (ASA≥3) and P-Possum-score, or with severe co-morbidities. For ASA 2 patients, the indication was given in case of a severe AC with rapid progression of biliary sepsis despite antibiotic therapy. With these indications, our clinical success rate was quite similar to previous reports. Blood and bile cultures encourage a speculation on the role of Enterococcus infection. These bacteria were commonly found in the bile but very rarely in the blood stream. Since the antibiotic therapy with piperacillin-tazobactam does not appropriately cover enterococcus species these data may be interpreted as the results of an early drain of the infected bile limiting a systemic spread of the infection or in alternative to consider enterococci as simple bile contaminants and not as pathogens. Conclusions A short PC catheter maintenance seems to be safe, feasible and effective in treating AC and appropriate to avoid surgery in very high risk patients. At the moment there is no sufficient evidences to suggest longer catheter maintenance. A strict follow-up to promptly evaluate potential recurrence and operate only selective cases is recommended. The results of the randomized multicenter study comparing laparoscopic cholecystectomy with percutaneous drainage (the CHOCOLATE trial) 79 in AC will help to clarify indications.
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TIMING OF PERCUTANEOUS CHOLECYSTOSTOMY TUBE REMOVAL
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Conflicts of interest.—The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Article first published online: June 9, 2016. - Manuscript accepted: June 7, 2016. - Manuscript received: April 15, 2016.
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Minerva Chirurgica
December 2016