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Meta-Analysis
. 2007 Oct 17;2007(4):CD006233.
doi: 10.1002/14651858.CD006233.pub2.

Cholecystectomy deferral in patients with endoscopic sphincterotomy

Affiliations
Meta-Analysis

Cholecystectomy deferral in patients with endoscopic sphincterotomy

V C McAlister et al. Cochrane Database Syst Rev. .

Abstract

Background: Cholecystectomy is not required in up to 64% of patients who adopt a wait-and-see policy after endoscopic clearance of common bile duct stones. Although reports of retrospective cohort series have shown a higher mortality among patients who defer cholecystectomy, it is not known if this is due to the patients' premorbid health status or due to the deferral of cholecystectomy. Randomised clinical trials of prophylactic cholecystectomy versus wait-and-see have not had sufficient power to demonstrate differences in survival.

Objectives: To evaluate the beneficial and harmful effects of cholecystectomy deferral (wait-and-see) versus elective (prophylactic) cholecystectomy in patients who have had an endoscopic biliary sphincterotomy.

Search strategy: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Controlled Trials Register (CENTRAL) in The Cochrane Library, MEDLINE (1966 to 2007), EMBASE (1980 to 2007), and Science Citation Index Expanded without language restrictions until April 2007.

Selection criteria: Randomised clinical trials comparing patients whose gallbladder was left in-situ after endoscopic sphincterotomy (wait-and-see group) versus patients who had cholecystectomy with either endoscopic sphincterotomy or common bile duct exploration (prophylactic cholecystectomy group), irrespective of blinding, language, or publication status.

Data collection and analysis: We assessed the impact of a wait-and-see policy on mortality. Secondary outcomes assessed were the incidence of biliary pain, cholangitis, pancreatitis, need for cholangiography, need for cholecystectomy, and the rate of difficult cholecystectomy. We pooled data using relative risk with fixed-effect and random-effects models.

Main results: We included 5 randomised trials with 662 participants out of 93 publications identified through the literature searches. The number of deaths was 47 in the wait-and-see group (334 patients) compared to 26 in the prophylactic cholecystectomy group (328 patients) for a 78% increased risk of mortality (RR 1.78, 95% CI 1.15 to 2.75, P = 0.010). The survival benefit of prophylactic cholecystectomy was independent of trial design, inclusion of high risk patients or inclusion of any one of the five trials. Patients in the wait-and-see group had higher rates of recurrent biliary pain (RR 14.56, 95% CI 4.95 to 42.78, P < 00001), jaundice or cholangitis (RR 2.53, 95% CI 1.09 to 5.87, P = 0.03), and of repeat ERCP or other forms of cholangiography (RR 2.36, 95% CI 1.29 to 4.32, P = 0.005). Cholecystectomy was eventually performed in 35% (115 patients) of the wait-and-see group.

Authors' conclusions: Prophylactic cholecystectomy should be offered to patients whose gallbladders remain in-situ after endoscopic sphincterotomy and common bile duct clearance.

PubMed Disclaimer

Conflict of interest statement

V McAlister is a surgeon who performs endoscopic retrograde cholangio‐pancreatography, common bile duct exploration, and cholecystectomy.

Figures

1.1
1.1. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 1 Mortality.
1.2
1.2. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 2 Biliary pain or cholecystitis.
1.3
1.3. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 3 Pancreatitis.
1.4
1.4. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 4 Recurrent jaundice or cholangitis.
1.5
1.5. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 5 Major adverse events.
1.6
1.6. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 6 Minor adverse events.
1.7
1.7. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 7 Additional cholangiography (ERCP or PTC).
1.8
1.8. Analysis
Comparison 1 Wait‐and‐see versus prophylactic cholecystectomy, Outcome 8 Difficult cholecystectomy.
2.1
2.1. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 1 Mortality.
2.2
2.2. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 2 Biliary pain or cholecystitis.
2.3
2.3. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 3 Pancreatitis.
2.4
2.4. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 4 Recurrent jaundice or cholangitis.
2.5
2.5. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 5 Major adverse events.
2.6
2.6. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 6 Minor adverse events.
2.7
2.7. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 7 Additional cholangiography (ERCP or PTC).
2.8
2.8. Analysis
Comparison 2 Stratified by method of cholecystectomy, Outcome 8 Difficult cholecystectomy.
3.1
3.1. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 1 Mortality.
3.2
3.2. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 2 Biliary pain or cholecystitis.
3.3
3.3. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 3 Pancreatitis.
3.4
3.4. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 4 Recurrent jaundice or cholangitis.
3.5
3.5. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 5 Major adverse events.
3.6
3.6. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 6 Minor adverse events.
3.7
3.7. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 7 Additional cholangiography (ERCP or PTC).
3.8
3.8. Analysis
Comparison 3 Stratified by patient ASA class, Outcome 8 Difficult cholecystectomy.

Update of

References

References to studies included in this review

Boerma 2002 {published data only}
    1. Boerma D, Rauws EA, Keulemans YC, Janssen IM, Bolwerk CJ, Timmer R, et al. Wait‐and‐see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile‐duct stones: a randomised trial. Lancet 2002;360:761‐5. [MEDLINE: ] - PubMed
Hammarstrom 1995 {published data only}
    1. Hammarstrom LE, Holmin T, Stridbeck H, Ihse I. Long‐term follow‐up of a prospective randomized study of endoscopic versus surgical treatment of bile duct calculi in patients with gallbladder in situ. BMJ (Clinical Research Ed.) 1995;82(11):1516‐21. [MEDLINE: ] - PubMed
Lau 2006 {published data only}
    1. Lau JY, Leow CK, Fung TM, Suen BY, Yu LM, Lai PB, et al. Cholecystectomy or gallbladder in situ after endoscopic sphincterotomy and bile duct stone removal in Chinese patients. Gastroenterology 2006;130(1):96‐103. [MEDLINE: ] - PMC - PubMed
Suc 1998 {published data only}
    1. Suc B, Escat J, Cherqui D, Fourtanier G, Hay JM, Fingerhut A, Millat B. Surgery vs endoscopy as primary treatment in symptomatic patients with suspected common bile duct stones. A multicenter randomized trial. Archives of Surgery 1998;133(7):702‐08. - PubMed
Targarona 1996 {published data only}
    1. Targarona EM, Ayuso RM, Bordas JM, Ros E, Pros I, Martinez J, et al. Randomised trial of endoscopic sphincterotomy with gallbladder left in situ versus open surgery for common bileduct calculi in high‐risk patients. Lancet 1996;347(9006):926‐9. [8598755] - PubMed

References to studies excluded from this review

Kapoor 1996 {published data only}
    1. Kapoor R, Kaushik S‐P, Saraswat V‐A, Choudhuri G, Sikora S‐S, Saxena R, et al. Prospective randomized trial comparing endoscopic sphincterotomy followed by surgery with surgery alone in good risk patients with choledocholithiasis. Hepatobiliary and Pancreatic Surgery 1996;9(3):145‐8. [MEDLINE: ] - PMC - PubMed
Neoptolemos 1987 {published data only}
    1. Neoptolemos JP, Carr Locke DL, Fossard DP. Prospective randomised study of preoperative endoscopic sphincterotomy versus surgery alone for common bile duct stones. British Medical Journal (Clinical Research Ed.) 1987;294(6570):470‐4. [MEDLINE: ] - PMC - PubMed

Additional references

Archibald 2007
    1. Archibald JD, Love JR, McAlister VC. The role of prophylactic cholecystectomy versus deferral in the care of patients after endoscopic sphincterotomy. Canadian Journal of Surgery 2007;50(1):19‐23. [MEDLINE: ] - PMC - PubMed
Barkun 2005
    1. Barkun J, Dixon E, Strasberg S, Evidence Based Reviews in Surgery Group. Canadian Association of General Surgeons and American College of Surgeons evidence based reviews in surgery. 13. Wait‐and‐see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile‐duct stones. Canadian Journal of Surgery 2005;48(3):244‐6. [MEDLINE: ] - PMC - PubMed
Cuschieri 2002
    1. Cuschieri A. Management of patients with gallstones and ductal calculi. Lancet 2002;360:739‐40. [MEDLINE: ] - PubMed
Escourrou 1984
    1. Escourrou J, Cordova JA, Lazorthes F, Frexinos J, Ribet A. Early and late complications after endoscopic sphincterotomy for biliary lithiasis with and without the gallbladder 'in situ'. Gut 1984;25:598‐602. [MEDLINE: ] - PMC - PubMed
ICH‐GCP 1997
    1. International Conference on Harmonisation Expert Working Group. Code of Federal Regulations & International Conference on Harmonization Guidelines. Media: Parexel Barnett, 1997.
Kjaergard 2001
    1. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta‐analyses. Annals of Internal Medicine 2001;135(11):982‐9. [MEDLINE: ] - PubMed
NIH 1992
    1. NIH Consensus Development Conference Statement. Gallstones and laparoscopic cholecystectomy. www.consensus.nih.gov/1992/1992GallstonesLaparoscopy090html.htm (accessed 23 August 2006).
NIH 2002
    1. National Institutes of Health State‐of‐the‐Science Conference Statement. Endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis and therapy. http://consensus.nih.gov/2002/2002ERCPsos020html.htm (accessed 23 August 2006).
RevMan 2003 [Computer program]
    1. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 4.2 for Windows. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2003.
Roy 1993
    1. Roy A, McAlister V, Passi RB. Endoscopic retrograde cholangiopancreatography in the management of choledocholithiasis with laparoscopic cholecystectomy. Canandian Journal of Surgery 1993;36:81‐4. [MEDLINE: ] - PubMed

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