Cholelithiasis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Larissa | Larissa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly | Larissa University Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative hospital stay | from onset of intervention to discharge | No | |
Secondary | success rate of CBD clearance | during ERCP | Yes | |
Secondary | failure rate of selective CBD cannulation | during ERCP | Yes | |
Secondary | incidence of multiple endoscopic procedures | within 30 days | Yes | |
Secondary | incidence of hyperamylasemia | within 48 hours post-ERCP | Yes | |
Secondary | incidence of severe pancreatitis (APACHE II score >6) | within 48 hours post-ERCP | Yes | |
Secondary | total hospital stay | from admission to discharge | No | |
Secondary | complications other but pancreatitis | within 30 days | Yes | |
Secondary | death | within 30 days | Yes |
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