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

NCT00416234 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2010-01-14

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Laparoendoscopic Rendez vous

intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy

PROCEDURE

preoperative ERCP and CBD clearance

ERCP and CBD clearance followed by laparoscopic cholecystectomy

Sponsors & Collaborators

  • Larissa University Hospital

    collaborator OTHER
  • University of Thessaly

    lead OTHER

Principal Investigators

  • Constantine Hatzitheofilou, MD · University of Thessaly, School of Medicine

  • George Tzovaras, MD · University of Thessaly, School of Medicine

  • Ioannis Baloyiannis, MD · University Hospital of Larissa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00416234 on ClinicalTrials.gov