Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis

Not Applicable

• Conditions: Choledocholithiasis; Cholelithiasis
• Interventions: Procedure: Laparoendoscopic Rendez vous; Procedure: preoperative ERCP and CBD clearance

• Registration Number: NCT00416234
• Lead Sponsor: University of Thessaly

Brief Summary

The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.

Detailed Description

The ideal management of concomitant cholelithiasis and choledocholithiasis is not known yet. There are several options, including one-stage or two-stage approaches. The most commonly used practice is the two-stage management which consists of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy. However, with this approach, a number of patients will be submitted to an unnecessary ERCP while some others will develop complications, mainly pancreatitis due to inadvertent pancreatic duct cannulation. Laparo-endoscopic rendez-vous methods have been described in order to obtain selective CBD cannulation and omit the risk of post-ERCP pancreatitis. In this procedure, during laparoscopic cholecystectomy, a wire is inserted through the cystic duct into the common bile duct, advanced into the duodenum where is found endoscopically, gripped with a snare and retrieved through the mouth. The a sphincterotome is inserted over the wire and elective CBD cannulation is obtained to be followed by sphincterotomy and CBD clearance intraoperatively. The method has been described by several authors in small to moderate case series, its safety has been proven and it appears that reduces both the length of hospital stay and the incidence of post-ERCP pancreatitis.However, it has not been popularized and has never been tested over the standard two-stage management. In our hospital, the standard approach for cholelithiasis and choledocholithiasis has been, as well, the two-stage (preop ERCP and sphincterotomy followed by laparoscopic cholecystectomy)approach. We initially assessed the feasibility and safety of the laparo-endoscopic rendez vous with a pilot study and now we intend to compare the two methods in a prospective randomized trial.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-12-26
• Study First Submitted QC: 2006-12-26
• Study First Posted: 2006-12-27
• Status Verified: 2008-06
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients must be able to give informed consent preoperatively
• ASA I-III
• patients at high risk to have CBD stones (jaundice, cholangitis, grossly deranged LFTs, CBD stones found on US or MRCP)

Exclusion Criteria

• patients not fit for surgery (ASA IV)
• previous ERCP and sphincterotomy
• previous upper abdominal surgery
• pregnancy at time of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Laparoendoscopic Rendez vous	Laparoendoscopic Rendez vous (one stage management of cholelithiasis/choledocholithiasis)
2	preoperative ERCP and CBD clearance	preoperative ERCP and CBD clearance followed by lap cholecystectomy (two stage management of cholelithiasis/choledocholithiasis)

Primary Outcome Measures

Name	Time	Method
postoperative hospital stay	from onset of intervention to discharge

Secondary Outcome Measures

Name	Time	Method
complications other but pancreatitis	within 30 days
death	within 30 days
incidence of severe pancreatitis (APACHE II score >6)	within 48 hours post-ERCP
failure rate of selective CBD cannulation	during ERCP
incidence of multiple endoscopic procedures	within 30 days
incidence of hyperamylasemia	within 48 hours post-ERCP
total hospital stay	from admission to discharge
success rate of CBD clearance	during ERCP

Trial Locations

Locations (1)

University Hospital of Larissa; 🇬🇷 Larissa, Thessaly, Greece