Choledocholithiasis, Cholelithiasis
Conditions
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.
Interventions
PROCEDURELaparoendoscopic Rendez vous
intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
PROCEDUREpreoperative ERCP and CBD clearance
ERCP and CBD clearance followed by laparoscopic cholecystectomy
Sponsors
Larissa University Hospital
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative hospital stay | from onset of intervention to discharge |
Secondary
| Measure | Time frame |
|---|---|
| failure rate of selective CBD cannulation | during ERCP |
| incidence of multiple endoscopic procedures | within 30 days |
| incidence of hyperamylasemia | within 48 hours post-ERCP |
| success rate of CBD clearance | during ERCP |
| total hospital stay | from admission to discharge |
| complications other but pancreatitis | within 30 days |
| death | within 30 days |
| incidence of severe pancreatitis (APACHE II score >6) | within 48 hours post-ERCP |
Countries
Greece
Contacts
Primary ContactGeorge Tzovaras, MD
Backup ContactIoannis Baloyiannis, MD
Outcome results
None listed