![]() |
Home
Search
Study Topics
Glossary
|
Study 1 of 8 for search of: | "Choledocholithiasis" |
![]() |
Previous Study | Return to Search Results | Next Study |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
University of Thessaly Larissa University Hospital |
---|---|
Information provided by: | University of Thessaly |
ClinicalTrials.gov Identifier: | NCT00416234 |
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: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Laparoendoscopic Rendez Vous (Intraoperative ERCP) vs Two Stage Approach (Preoperative ERCP Followed by Laparoscopic Cholecystectomy) for the Management of Cholelithiasis/Choledocholithiasis |
Estimated Enrollment: | 300 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Laparoendoscopic Rendez vous (one stage management of cholelithiasis/choledocholithiasis)
|
Procedure: Laparoendoscopic Rendez vous
intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
|
2: Active Comparator
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: George Tzovaras, MD | +30 2410 682730 | gtzovaras@hotmail.com |
Contact: Ioannis Baloyiannis, MD | +30 2410 682728 | balioan@hotmail.com |
Greece, Thessaly | |
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 |
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 |
Responsible Party: | University of Thessaly, School of Medicine ( George Tzovaras, MD ) |
Study ID Numbers: | Larissa CBD stones trial |
Study First Received: | December 26, 2006 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00416234 |
Health Authority: | Greece: Ministry of Health and Welfare |
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases Cholelithiasis |
Bile Duct Diseases Gallstones Biliary Tract Diseases Calculi Choledocholithiasis |
Common Bile Duct Diseases |