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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Thessaly.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Larissa University Hospital
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00416234
First received: December 26, 2006
Last updated: January 13, 2010
Last verified: June 2008
  Purpose

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.


Condition Intervention
Choledocholithiasis
Cholelithiasis
Procedure: Laparoendoscopic Rendez vous
Procedure: preoperative ERCP and CBD clearance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoendoscopic Rendez Vous (Intraoperative ERCP) vs Two Stage Approach (Preoperative ERCP Followed by Laparoscopic Cholecystectomy) for the Management of Cholelithiasis/Choledocholithiasis

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • postoperative hospital stay [ Time Frame: from onset of intervention to discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • success rate of CBD clearance [ Time Frame: during ERCP ] [ Designated as safety issue: Yes ]
  • failure rate of selective CBD cannulation [ Time Frame: during ERCP ] [ Designated as safety issue: Yes ]
  • incidence of multiple endoscopic procedures [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  • incidence of hyperamylasemia [ Time Frame: within 48 hours post-ERCP ] [ Designated as safety issue: Yes ]
  • incidence of severe pancreatitis (APACHE II score >6) [ Time Frame: within 48 hours post-ERCP ] [ Designated as safety issue: Yes ]
  • total hospital stay [ Time Frame: from admission to discharge ] [ Designated as safety issue: No ]
  • complications other but pancreatitis [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  • death [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416234

Contacts
Contact: George Tzovaras, MD +30 2410 682730 gtzovaras@hotmail.com
Contact: Ioannis Baloyiannis, MD +30 2410 682728 balioan@hotmail.com

Locations
Greece
University Hospital of Larissa Recruiting
Larissa, Thessaly, Greece, 413 35
Contact: George Tzovaras, MD    +30 2410 682730    gtzovaras@hotmail.com   
Principal Investigator: Ioannis Baloyiannis, MD         
Sub-Investigator: Spyros Potamianos, MD         
Sub-Investigator: George Paroutoglou, MD         
Sub-Investigator: Georgia Stamatiou, MD         
Sponsors and Collaborators
University of Thessaly
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
  More Information

No publications provided by University of Thessaly

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Tzovaras, MD, University of Thessaly, School of Medicine
ClinicalTrials.gov Identifier: NCT00416234     History of Changes
Other Study ID Numbers: Larissa CBD stones trial
Study First Received: December 26, 2006
Last Updated: January 13, 2010
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Choledocholithiasis
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases

ClinicalTrials.gov processed this record on April 17, 2014