Another approach is to facilitate the performance of post-operative ERCP and sphincterotomy by inserting a stent transcystically at the time of laparoscopic cholecystectomy. Facilitated ERCP has recently been reported in a prospective consecutive series from Nepean Hospital. Failure to access the common bile duct at first attempt was 1.2% in this series, which compares favourably with duct access failure rates – reported in the literature – of 5-12% without the facilitation of a stent. The incidence of pancreatitis, bleeding and duodenal perforation after facilitated ERCP was 0%, 0% and 0.6%, respectively. Two cases (1.2%) of cholangitis were also reported. Comparison to other series suggests that facilitated ERCP offers real advantages over the conventional unfacilitated ERCP for bile duct stone removal, which has a reported pancreatitis rate of 2-11% (and our own rate of 8%); a bleeding rate of 2-4 % and a duodenal perforation rate of 1-4%. The mortality rates of these ERCP techniques cannot be compared at this preliminary stage because of insufficient numbers in the Nepean series.
Prior to the laparoscopic era cholecystectomy patients with bile duct stones were managed surgically during open cholecystectomy (OC), with direct exploration of their common bile duct (choledochotomy). However, open surgical bile duct exploration waned in popularity and progressively stones were dealt with endoscopically, either pre or post cholecystectomy. As laparoscopic technology advances, simultaneous clearance of the bile duct at the time of laparoscopic cholecystectomy is regaining popularity.
Some surgeons elect to remove bile duct stones at the index operation through the cystic duct. This approach has a success rate of between 75 and 90%. When there is failure to clear the bile duct transcystically, some surgeons proceed to a choledochotomy to clear the duct, while others close the cystic duct stump, leaving the stones in situ to be removed at a later date by endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy. The argument in favour of immediate choledochotomy is that the duct may be cleared in one sitting. The argument against it is that the morbidity of choledochotomy is considerable. The argument for a subsequent ERCP is that the morbidity of choledochotomy is avoided. The argument against subsequent ERCP is that there may be difficulty cannulating the common bile duct and that ERCP with sphincterotomy is associated with a significant morbidity, particularly pancreatitis.
Symptomatic gallstone disease is common. In the year July 2001-2002, laparoscopic cholecystectomy was performed on 5,235 patients in NSW public hospitals. Up to 18% of patients undergoing laparoscopic cholecystectomy for gallstones may have concomitant common bile duct stones (choledocholithiasis). Twenty-five percent of bile duct stones are completely unsuspected. Therefore the optimal management of bile duct stones is a significant issue for all general surgeons who perform this very common operation. Yet, the management of these patients in the laparoscopic era remains contentious.
This study is designed to assess whether a new technique called facilitated endoscopic retrograde cholangiopancreatography (ERCP) is or is not superior to conventional ERCP for removing stones found in the bile duct at the time of laparoscopic cholecystectomy. ERCP is an endoscopic procedure used to facilitate the radiological examination and subsequent manipulation of the common bile duct (eg. opening it up, which is called sphincterotomy). Both facilitated and conventional ERCP are performed as a separate procedure after the initial gallbladder surgery. This is a comparative study of these two techniques in a randomised clinical trial.
An alternative approach taken by the majority of surgeons in NSW when confronted by common bile duct stones at laparoscopic cholecystectomy is to close the cystic duct stump in all patients, without exploring the duct transcystically. Stones are left in situ, to be removed at a later date endoscopically – by ERCP and sphincterotomy. The attendant risks of this approach are mentioned above.
The aim of this randomised clinical trial is to enable surgeons to decide whether placement of a plastic stent at the time of laparoscopic cholecystectomy will improve the success rate and safety of subsequent ERCP and sphincterotomy.
Included in the cohort were 346 consecutive patients with common bile duct stones, 16 (4.6%) of whom were converted to open surgery because of the following conditions: 1) the narrow or tortuous cystic duct, 2) dense fibrotic adhesion with obscured anatomy, 3) impacted stone, 4) laparoscopic failure, 5) rupture of the cystic duct, 6) intrahepatic stone, 7) cholecystoduodenal fistula, 8) gallbladder bed bleeding, and 9) duodenum injury (Table 1 ). In The remaining 330 patients, 237 underwent LTSE and 93 required LC. In the LC group, all patients were randomly assigned to either the primary closure (n = 47) or the T-tube drainage (n = 46) groups.
At the end of the procedure, a single infrahepatic suction drain was placed. This was removed 48–96 h later if there was no bile leakage. Patients in the T-tube group had a cholangiogram on the third to fifth postoperative day. If the finding was normal, the T-tube was clamped and patients were discharged home with the T-tube.
Discharge and follow-up
Complication rates for patients after LCBDE via transcystic approach versus choledochotomy
Included in this prospective study cohort were all patients with CBDS and gallbladder stones treated with laparoscopic common bile duct stone extraction (LCBDE) at the Nanjing Drum Tower Hospital and the 101st hospital of the People Liberation Army in China over the period from May 2000 to February 2009. We collected and analyzed patient clinical presentations, laboratory test results, ultrasonography, magnetic resonance cholangiopancreatography (MRCP), or intraoperative cholangiography (IOC). Patient consent for endoscopic surgery and research was obtained before the procedure was started. The study protocol was approved by the Ethics Committee of the Nanjing Drum tower Hospital and the 101st hospital. The protocol was implemented in accordance with provisions of the Declaration of Helsinki and Good Clinical Practice guidelines.
Laparoscopic transcystic stone extraction (LTSE)
Values that were significant are in boldface.