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

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ClinicalTrials.gov Identifier: NCT00416234
Recruitment Status : Unknown
Verified June 2008 by University of Thessaly.
Recruitment status was:  Recruiting
First Posted : December 27, 2006
Last Update Posted : January 14, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Choledocholithiasis Cholelithiasis Procedure: Laparoendoscopic Rendez vous Procedure: preoperative ERCP and CBD clearance

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2006
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. postoperative hospital stay [ Time Frame: from onset of intervention to discharge ]

Secondary Outcome Measures :
  1. success rate of CBD clearance [ Time Frame: during ERCP ]
  2. failure rate of selective CBD cannulation [ Time Frame: during ERCP ]
  3. incidence of multiple endoscopic procedures [ Time Frame: within 30 days ]
  4. incidence of hyperamylasemia [ Time Frame: within 48 hours post-ERCP ]
  5. incidence of severe pancreatitis (APACHE II score >6) [ Time Frame: within 48 hours post-ERCP ]
  6. total hospital stay [ Time Frame: from admission to discharge ]
  7. complications other but pancreatitis [ Time Frame: within 30 days ]
  8. death [ Time Frame: within 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 27, 2006    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: June 2008

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