Clinical trial NCT00416234: Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis
Official title: Laparoendoscopic Rendez Vous (Intraoperative ERCP) vs Two Stage Approach (Preoperative ERCP Followed by Laparoscopic Cholecystectomy) for the Management of Cholelithiasis/Choledocholithiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Choledocholithiasis
Cholelithiasis
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: Larissa University Hospital
First posted: 2006-12-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative hospital stay
timeFrame: from onset of intervention to discharge
Secondary outcomes:
measure: success rate of CBD clearance
timeFrame: during ERCP
measure: failure rate of selective CBD cannulation
timeFrame: during ERCP
measure: incidence of multiple endoscopic procedures
timeFrame: within 30 days
measure: incidence of hyperamylasemia
timeFrame: within 48 hours post-ERCP
measure: incidence of severe pancreatitis (APACHE II score >6)
timeFrame: within 48 hours post-ERCP
measure: total hospital stay
timeFrame: from admission to discharge
measure: complications other but pancreatitis
timeFrame: within 30 days
measure: death
timeFrame: within 30 days
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
Study officials:
affiliation: University of Thessaly, School of Medicine
name: Constantine Hatzitheofilou, MD
role: STUDY_CHAIR
affiliation: University of Thessaly, School of Medicine
name: George Tzovaras, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Larissa
name: Ioannis Baloyiannis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tzovaras G, Baloyiannis I, Zachari E, Symeonidis D, Zacharoulis D, Kapsoritakis A, Paroutoglou G, Potamianos S. Laparoendoscopic rendezvous versus preoperative ERCP and laparoscopic cholecystectomy for the management of cholecysto-choledocholithiasis: interim analysis of a controlled randomized trial. Ann Surg. 2012 Mar;255(3):435-9. doi: 10.1097/SLA.0b013e3182456ec0.