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

January 13, 2010 updated by: University of Thessaly

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 413 35
        • Recruiting
        • University Hospital Of Larissa
        • Contact:
        • Principal Investigator:
          • Ioannis Baloyiannis, MD
        • Sub-Investigator:
          • Spyros Potamianos, MD
        • Sub-Investigator:
          • George Paroutoglou, MD
        • Sub-Investigator:
          • Georgia Stamatiou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Laparoendoscopic Rendez vous (one stage management of cholelithiasis/choledocholithiasis)
Procedure: Laparoendoscopic Rendez vous
intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
Active Comparator: 2
preoperative ERCP and CBD clearance followed by lap cholecystectomy (two stage management of cholelithiasis/choledocholithiasis)
Procedure: preoperative ERCP and CBD clearance
ERCP and CBD clearance followed by laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative hospital stay
Time Frame: from onset of intervention to discharge
from onset of intervention to discharge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Collaborators

Larissa University Hospital

Investigators

  • Study Chair: Constantine Hatzitheofilou, MD, University of Thessaly, School of Medicine
  • Study Director: George Tzovaras, MD, University of Thessaly, School of Medicine
  • Principal Investigator: Ioannis Baloyiannis, MD, University Hospital Of Larissa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

December 26, 2006

First Submitted That Met QC Criteria

December 26, 2006

First Posted (Estimate)

December 27, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Larissa CBD stones trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholelithiasis

Clinical Trials on Laparoendoscopic Rendez vous

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe