Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy
Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy
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.

 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.
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.

 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.

 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.

 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.
Inclusion Criteria:

 -  The patient must be able to give informed consent preoperatively (i.e. elective
 procedures only)

 -  Patients at higher than normal risk of having CBD stones identified at OC. For
 example: *CBD stones identified at ultrasound; *Wide CBD (>6mm) at ultrasound;
 *Previous, recent, current cholangitis, jaundice, or biliary pancreatitis; or
 *Abnormal AST and ALT levels (>2 times normal).

 Exclusion Criteria:

 -  Pregnancy at time of surgery

 -  Patients not fit for surgery. For example: *Those with acute cholecystitis or
 persistent obstructive jaundice; *Patients who have had a previous ERCP and
 sphincterotomy; or *Patients in whom intervention was not technically possible (eg.
 previous Billroth II gastrectomy).