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

Cholelithiasis Clinical Trial

Official title:

Laparoendoscopic Rendez Vous (Intraoperative ERCP) vs Two Stage Approach (Preoperative ERCP Followed by Laparoscopic Cholecystectomy) for the Management of Cholelithiasis/Choledocholithiasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00416234
• Other study ID #: Larissa CBD stones trial
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2006
• Last updated: January 13, 2010
• Start date: September 2006
• Est. completion date: December 2010

Study information

• Verified date: June 2008
• Source: University of Thessaly
• Contact: George Tzovaras, MD
• Phone: +30 2410 682730
• Email: gtzovaras[@]hotmail.com
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Choledocholithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Laparoendoscopic Rendez vous
intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
• preoperative ERCP and CBD clearance
ERCP and CBD clearance followed by laparoscopic cholecystectomy

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa	Thessaly

Sponsors (2)

Lead Sponsor	Collaborator
University of Thessaly	Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative hospital stay		from onset of intervention to discharge	No
Secondary	success rate of CBD clearance		during ERCP	Yes
Secondary	failure rate of selective CBD cannulation		during ERCP	Yes
Secondary	incidence of multiple endoscopic procedures		within 30 days	Yes
Secondary	incidence of hyperamylasemia		within 48 hours post-ERCP	Yes
Secondary	incidence of severe pancreatitis (APACHE II score >6)		within 48 hours post-ERCP	Yes
Secondary	total hospital stay		from admission to discharge	No
Secondary	complications other but pancreatitis		within 30 days	Yes
Secondary	death		within 30 days	Yes