K S Gurusamy1, K Samraj. 1. Royal Free Hospital, General Surgery, Pond Street, London, UK, NW3 2QG. kurinchi2k@hotmail.com
Abstract
BACKGROUND: Between 5% and 11% of people undergoing cholecystectomy have common bile duct stones. Open common bile duct exploration is an important operation when endoscopic retrograde cholangio-pancreatography fails or when expertise for laparoscopic common bile duct exploration is not available. The optimal method for performing open common bile duct exploration is unclear. OBJECTIVES: The aim is to assess the benefits and harms of primary closure versus routine T-tube drainage in open common bile duct exploration for common bile duct stones. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until January 2006. SELECTION CRITERIA: We considered for inclusion all randomised clinical trials comparing primary closure (with or without biliary stent) versus T-tube drainage after open common bile duct exploration. DATA COLLECTION AND ANALYSIS: We collected the data on the characteristics, methodological quality, mortality, morbidity, operating time, and hospital stay from each trial. We analysed the data with both the fixed-effect and the random-effects model using RevMan Analysis. For each outcome we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis. MAIN RESULTS: We included five trials with 324 patients randomised: 165 to primary closure without stent and 159 to T-tube. Three of the five trials were considered to have adequate methodological quality, but all lacked blinded outcome assessment. The primary closure group had significantly lower positive bile culture (3 trials, OR 0.22, 95% CI 0.10 to 0.45) and wound infection (5 trials, OR 0.29, 95% CI 0.15 to 0.56). When only trials with high methodological quality were included, there was no statistically significant difference in any of the outcomes except positive bile culture, which became non-significant when the random-effects model was used. The deaths of the three patients in the T-tube group were directly related to surgery and sepsis. Bile peritonitis was higher in the T-tube group (2.9%) than in the primary closure group (1%) (not statistically significant). Hospital stay was significantly longer in the T-tube group compared with the primary closure group in three of the four trials, which reported on the hospital stay. The only trial comparing primary closure with stent (37 patients) versus T-tube drainage (44 patients) did not reveal any statistically significant difference in any of the reported outcomes (mortality, re-operations, wound infection, and hospital stay). There was one case of stent migration, which could not be retrieved after two attempts of ERCP. AUTHORS' CONCLUSIONS: Primary closure after common bile duct exploration seems at least as safe as T-tube drainage. We need randomised trials that assess whether stents may offer benefits.
BACKGROUND: Between 5% and 11% of people undergoing cholecystectomy have common bile duct stones. Open common bile duct exploration is an important operation when endoscopic retrograde cholangio-pancreatography fails or when expertise for laparoscopic common bile duct exploration is not available. The optimal method for performing open common bile duct exploration is unclear. OBJECTIVES: The aim is to assess the benefits and harms of primary closure versus routine T-tube drainage in open common bile duct exploration for common bile duct stones. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until January 2006. SELECTION CRITERIA: We considered for inclusion all randomised clinical trials comparing primary closure (with or without biliary stent) versus T-tube drainage after open common bile duct exploration. DATA COLLECTION AND ANALYSIS: We collected the data on the characteristics, methodological quality, mortality, morbidity, operating time, and hospital stay from each trial. We analysed the data with both the fixed-effect and the random-effects model using RevMan Analysis. For each outcome we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis. MAIN RESULTS: We included five trials with 324 patients randomised: 165 to primary closure without stent and 159 to T-tube. Three of the five trials were considered to have adequate methodological quality, but all lacked blinded outcome assessment. The primary closure group had significantly lower positive bile culture (3 trials, OR 0.22, 95% CI 0.10 to 0.45) and wound infection (5 trials, OR 0.29, 95% CI 0.15 to 0.56). When only trials with high methodological quality were included, there was no statistically significant difference in any of the outcomes except positive bile culture, which became non-significant when the random-effects model was used. The deaths of the three patients in the T-tube group were directly related to surgery and sepsis. Bile peritonitis was higher in the T-tube group (2.9%) than in the primary closure group (1%) (not statistically significant). Hospital stay was significantly longer in the T-tube group compared with the primary closure group in three of the four trials, which reported on the hospital stay. The only trial comparing primary closure with stent (37 patients) versus T-tube drainage (44 patients) did not reveal any statistically significant difference in any of the reported outcomes (mortality, re-operations, wound infection, and hospital stay). There was one case of stent migration, which could not be retrieved after two attempts of ERCP. AUTHORS' CONCLUSIONS: Primary closure after common bile duct exploration seems at least as safe as T-tube drainage. We need randomised trials that assess whether stents may offer benefits.