Laparoscopic exploration of common bile duct with primary closure versus T-tube drainage: a randomized clinical trial. Primary duct closure versus T-tube drainage following exploration of the common bile duct. Is the use of T-tube necessary after laparoscopic choledochotomy? Primary closure versus T-tube drainage after open choledochotomy. A randomized comparison of primary closure and T-tube drainage of the common bile duct after laparoscopic choledochotomy. Choledochotomy for biliary lithiasis: T-tube drainage or primary closure. Effects on postoperative bacteremia and T-tube bile infection. Randomised trial of laparoscopic exploration of common bile duct versus postoperative endoscopic retrograde cholangiography for common bile duct stones. Precholecystectomy endoscopic cholangiography and stone removal is not superior to cholecystectomy, cholangiography, and common duct exploration. A controlled trial of drainage after cholecystectomy. Prospective randomised study of preoperative endoscopic sphincterotomy versus surgery alone for common bile duct stones. Postoperative ERCP versus laparoscopic choledochotomy for clearance of selected bile duct calculi: a randomized trial.
Traditionally, the common bile duct (CBD) is closed with T-tube drainage after choledochotomy and removal of CBD stones. However, the insertion of a T-tube is not without complication and the patients have to carry it for several weeks before removal. In the laparoscopic era, surgery is performed with minimally invasive techniques in order to reduce the trauma, hasten recovery, and reduce the hospital stay of patients. T-tube insertion seems to negate these benefits. This randomized study was designed to compare the two methods applied after LCBDE and to determine whether primary closure can be as safe as closure with T-tube drainage.
                From May 2000 to January 2008, 93 consecutive patients with common bile duct stones (CBDS) and gallbladder in situ were enrolled in this randomized study to undergo laparoscopic cholecystectomy with laparoscopic common bile duct exploration (LCBDE). Intraoperative findings, postoperative complications, postoperative stay, and hospital expenses were recorded and analyzed.
                There was no mortality in both groups. A T-tube was inserted in 46 patients and the CBD was closed primarily in 47. There were no differences in the demographic characteristics or clinical presentations between the two groups. Compared with the T-tube group, the operative time and postoperative stay were significantly shorter, the hospital expenses were significantly lower, and the incidences of overall postoperative complications and biliary complications were statistically and insignificantly lower in the primary closure group.
                LCBDE with primary closure without external drainage after laparoscopic choledochotomy is feasible and as safe as T-tube insertion. T-tube drainage of the common bile duct (CBD) following duct exploration has become standard surgical practice. This randomized prospective study has compared primary closure versus T-tube drainage of the CBD following exploration for calculous disease. Thirty-seven patients underwent primary closure and 26 underwent closure over T-tube. Both groups were comparable in terms of age, indications for surgery, associated illnesses, pre-operative bilirubin, amylase and white cell count. Forty-three per cent of operations were performed by a consultant in the primary closure group and 65% in the T-tube group. There was no significant difference in the duration of operation, incidence of wound infection, surgical or other complications following operation between the two groups. However, the postoperative stay was significantly prolonged in the T-tube group, to a median of 11 days, compared to 8 days in the primary closure group (P = 0.0001). This prolongation in stay was unrelated to whether admission was as an emergency or elective. T-tube drainage of the bile continued for a median of 7 days postoperative, whereas the bile drained via a wound drain in only 13 (35%) of the primary closure group, for a median of 5 days in these 13 patients. Long-term follow up was achieved in 48 patients, by a questionnaire sent at a median of 2.8 years following operation. Abdominal pains following recovery from the operation were experienced by 18% of the primary closure group and 20% of the T-tube group. No patient developed jaundice or pancreatitis, nor needed further biliary surgery following operation.(ABSTRACT TRUNCATED AT 250 WORDS) Traditionally, the common bile duct (CBD) is closed with T-tube drainage after choledochotomy and removal of CBD stones. However, the insertion of a T-tube is not without complication.
                This randomized study was designed to compare the use of T-tube and primary closure of choledochotomy after laparoscopic choledochotomy to determine whether primary closure can be as safe as closure with T-tube drainage.
                Between February 2006 and June 2009, 122 consecutive patients with proven choledocholithiasis had laparoscopic choledochotomy. They were randomized into two equal groups: T-tube (n = 61) and primary closure (n = 61). Demographic data, intraoperative findings, postoperative complications, and postoperative stay were recorded.
                There was no mortality in both groups. There were no differences in the demographic characteristics or clinical presentations between the two groups. Compared with the T-tube group, the operative time and postoperative stay were significantly shorter and the incidences of overall postoperative complications and biliary complications were statistically and significantly lower in the primary closure group.
                Laparoscopic common bile duct exploration with primary closure without external drainage after laparoscopic choledochotomy is feasible, safe, and cost-effective. After verification of ductal clearance, the CBD could be closed primarily without T-tube insertion. Choledochotomy followed by T-tube has long been a standard surgical treatment for choledocholithiasis. It is still a preferred choice in many hospitals where minimal invasive procedures are not feasible. The use of T-tube is not without complications. To avoid the complications associated with T-tube, we have performed primary closure of the common bile duct (CBD) after exploration. This pilot study assesses the safety of primary closure of CBD, which would help form a basis for implementation on a wider scale.
                To compare the clinical results of primary closure with T-tube drainage after open choledochotomy and assess the safety of primary closure for future application on a greater mass.
                This comparative study was conducted at surgical unit IV Liaquat University of Medical and Health Sciences, Jamshoro, from January 2007 to December 2007. Thirty-five patients were included in the study of which 16 patients underwent primary closure.
                Thirty-five patients were included in the study. The mean age of patients who had primary closure done (n = 16) was 46.0 +/-16.8 and there were two (12.5%) males and 14 (87.5%) females. After primary closure of the CBD, bile leakage was noted in one patient (6.3%), which subsided without any biliary peritonitis as compared to the T-tube group in which two patients (10.5%) had bile leakage. Postoperative jaundice was seen in one patient (5.3%) who had a T-tube because of a blockage of CBD. Not a single patient had a retained stone in both groups as well as no recurrence of CBD stones. The postoperative hospital stay after primary closure was 5.56 +/-1.1 days as compared to after T-tube drainage which was 13.6 +/-2.3 days. The total cost of treatment in patients who underwent primary closure was USD194.5 +/-41.5 but after T-tube drainage it was USD548.6 +/-88.5. The median follow up duration for both groups was 6 months.
                Primary CBD closure is a safe and cost effective alternative to routine T-tube drainage after open choledochotomy. Traditionally, the common bile duct (CBD) has been closed with T-tube drainage after laparoscopic choledochotomy and removal of CBD stones. However, insertion of the T-tube is related to some potential postoperative complications, and patients must carry the T-tube for several weeks before its removal. Primary closure of the CBD without drainage has been proposed as a safe alternative to T-tube placement after laparoscopic choledochotomy. This randomized study aimed to compare the postoperative course and final outcome between the two methods applied after LCBDE.
                Between January 2000 and January 2004, 80 patients treated with laparoscopic choledochotomy for CBD stones were randomly assigned to primary duct closure (n = 40) or T-tube drainage (n = 40). The primary end points were morbidity, operative time, postoperative stay, hospital expenses, and time until return to work.
                There were no differences in the demographic characteristics or clinical presentations between the two groups. In the primary closure group, the postoperative stay (5.2 +/- 2.2 vs 8.3 +/- 3.6 days) and the time until return to work (12.6 +/- 5.1 vs 20.4 +/- 13.2 days) were significantly shorter, the hospital expenses (8,638 +/- 2,946 vs 12,531 +/- 4,352 yuan) were significantly lower, and the incidences of postoperative complications (15% vs 27.5%) and biliary complications (10% vs 20%) were statistically and insignificantly lower than in the T-tube drainage group. In the primary closure group, six patients experienced postoperative complications, four of whom had biliary complications, compared, respectively, with 11 and 8 patients in the T-tube drainage group.
                This study showed that primary CBC closure after laparoscopic choledochotomy was a viable alternative to mandatory T-tube drainage. To compare the incidence of postoperative bacteremia in patients with biliary lithiasis after choledochotomy supplemented by either T-tube drainage or primary common bile duct closure, 117 patients who underwent surgery are presented in this clinical trial. It has been shown that primary common bile duct closure is associated with a lower incidence of postoperative bacteremia (3.3 percent), a lower mortality rate (0 percent), and a lower early morbidity rate (13.3 percent) than T-tube drainage (31.5, 3.5, and 36.1 percent, respectively). The above evidence supports the view that T-tube drainage might well provoke the exogenous acquisition of environmental microorganisms and thus promote further infection. The management of stones in the common bile duct in the laparoscopic era is controversial. The three major options are preoperative endoscopic retrograde cholangiography (ERCP), laparoscopic exploration of the common bile duct (LECBD), or postoperative ERCP.
                Between August, 1995, and August, 1997, 471 laparoscopic cholecystectomies were done in our department. In 427 (91%), satisfactory peroperative cholangiography was obtained. In 80 (17%) of these cases there were stones in the common bile duct, 40 patients were randomised to LECBD and 40 to postoperative ERCP. If LECBD failed, patients had either open exploration of the common bile duct or postoperative ERCP. If one postoperative ERCP failed, the procedure was repeated until the common bile duct was cleared of stones or an endoprosthesis was placed to prevent stone impaction. The primary endpoints were duct-clearance rates, morbidity, operating time, and hospital stay. Analyses were by intention to treat.
                Age and sex distribution of patients was similar in the randomised groups. Duct clearance after the first intervention was 75% in both groups. By the end of treatment, duct clearance was 100% in the laparoscopic group compared with 93% in the ERCP group. Duration of treatment was a median of 90 min (range 25-310) in the laparoscopic group (including ERCPs for failed LECBD) compared with 105 min (range 60-255) in the postoperative ERCP group (p = 0.1, 95% CI for difference -5 to 40). Hospital stay was a median of 1 day (range 1-26) in the laparoscopic group compared with 3.5 days (range 1-11) in the ERCP group (p = 0.0001, 95% CI 1-2).
                LECBD is as effective as ERCP in clearing the common bile duct of stones. There is a non-significant trend to shorter time in the operating theatre and a significantly shorter hospital stay in patients treated by LECBD. Thirty-four patients with suspected common bile duct stones were randomized to undergo endoscopic cholangiography and stone removal prior to open cholecystectomy or to have open cholecystectomy, operative cholangiography, and common bile duct exploration. Sixteen underwent the first protocol, and 18 the second. Analysis of the ability to clear stones from the common bile duct, morbidity, mortality, hospital stay, length of operation, and hospital cost showed no difference in outcome between patients treated by either method. These data suggest there is neither an advantage nor a disadvantage to treating patients with suspected duct stones by precholecystectomy endoscopic cholangiography and stone removal. A prospective controlled trial of drainage after cholecystectomy has been carried out. In a consecutive series of 143 patients undergoing cholecystectomy, 50 patients were randomly allocated to a drainage group and a further 50 patients to a non-drainage group. The remaining 43 patients were drained electively because the common bile duct was explored or because of infection or incomplete haemostasis. There was no significant difference in the incidence of wound infection or other complications between the drainage and the non-drainage groups. The duration of postoperative pyrexia, the number of analgesic injections and the length of postoperative hospital stay were the same in both the randomized groups. One patient in the randomized drainage group had a reactionary haemorrhage from the drain site requiring transfusion. There was no mortality but one patient in the elective drainage group had to be re-explored for a subhepatic abscess. Three patients in this group drained bile from the drain for 3-9 days but all had a T tube in place. This trial fails to demonstrate any advantage or disadvantage in draining the gallbladder bed after cholecystectomy. One hundred and twenty patients with known common bile duct stones were entered into a prospective randomised study of preoperative endoscopic sphincterotomy and stone clearance (group 1) versus surgery alone (group 2). Five patients were incorrectly entered; the 55 patients randomised to group 1 and the 60 randomised to group 2 were well matched with respect to clinical features and biochemical and medical risk factors. In group 1 endoscopic stone clearance was successful in 50 patients (91%); five of these patients refused elective surgery, though this was subsequently necessary in one. In group 2 common bile duct stones were cleared surgically in 54 of 59 patients (91.5%); one patient was treated by endoscopic sphincterotomy alone because of a myocardial infarct. The overall major complication rate in group 1 was 16.4% and included two deaths; in group 2 this was 8.5% and included one death. The minor complication rate in group 1 was 16.4% and that in group 2 13.6%. These differences in outcome were not significant. Despite a significant reduction in total hospital stay of patients in group 1, these results do not support the routine use of preoperative endoscopic sphincterotomy in patients having biliary surgery for stones in the common bile duct. Prospectively evaluate whether for patients having laparoscopic cholecystectomy with failed trans-cystic duct clearance of bile duct (BD) stones they should have laparoscopic choledochotomy or postoperative endoscopic retrograde cholangiography (ERCP).
                Clinical management of BD stones found at laparoscopic cholecystectomy in the last decade has focused on pre-cholecystectomy detection with ERCP clearance in those with suspected stones. This clinical algorithm successfully clears the stones in most patients, but no stones are found in 20% to 60% of patients and rare unpredictably severe ERCP morbidity can result in this group. Our initial experience of 300 consecutive patients with fluoroscopic cholangiography and intraoperative clearance demonstrated that, for the pattern of stone disease we see, 66% of patients' BD stones can be cleared via the cystic duct with dramatic reduction in morbidity compared to the 33% requiring choledochotomy or ERCP. Given the limitations of the preoperative approach to BD stone clearance, this trial was designed to explore the limitations, for patients failing laparoscopic trans-cystic clearance, of laparoscopic choledochotomy or postoperative ERCP.
                Across 7 metropolitan hospitals after failed trans-cystic duct clearance, patients were intraoperatively randomized to have either laparoscopic choledochotomy or postoperative ERCP. Exclusion criteria were: ERCP prior to referral for cholecystectomy, severe cholangitis or pancreatitis requiring immediate ERCP drainage, common BD diameter of less than 7 mm diameter, or if bilio-enteric drainage was required in addition to stone clearance. Drain decompression of the cleared BD was used in the presence of cholangitis, an edematous ampulla due to instrumentation or stone impaction and technical difficulties from local inflammation and fibrosis. The ERCP occurred prior to discharge from hospital. Mechanical and extracorporeal shockwave lithotripsy was available. Sphincter balloon dilation as an alternative to sphincterotomy to allow stone extraction was not used. Major endpoints for the trial were operative time, morbidity, retained stone rate, reoperation rate, and hospital stay.
                From June 1998 to February 2003, 372 patients with BD stones had successful trans-cystic duct clearance of stones in 286, leaving 86 patients randomized into the trial. Total operative time was 10.9 minutes longer in the choledochotomy group (158.8 minutes), with slightly shorter hospital stay 6.4 days versus 7.7 days. Bile leak occurred in 14.6% of those having choledochotomy with similar rates of pancreatitis (7.3% versus 8.8%), retained stones (2.4% versus 4.4%), reoperation (7.3% versus 6.6%), and overall morbidity (17% versus 13%).
                These data suggest that the majority of secondary BD stones can be diagnosed at the time of cholecystectomy and cleared trans-cystically, with those failing having either choledochotomy or postoperative ERCP. However, because of the small trial size, a significant chance exists that small differences in outcome may exist. We would avoid choledochotomy in ducts less than 7 mm measured at the time of operative cholangiogram and severely inflamed friable tissues leading to a difficult dissection. We would advocate choledochotomy as a good choice for patients after Billroth 11 gastrectomy, failed ERCP access, or where long delays would occur for patient transfer to other locations for the ERCP.
T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.