Clinical Trial: Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patie
Brief Summary: The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.
Detailed Summary:
Sponsor: North Bristol NHS Trust
Current Primary Outcome: Bile duct clearance [ Time Frame: Peri-operative ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Morbidity and mortality [ Time Frame: 30 day or directly relating to intervention ]
- Post-operative stay [ Time Frame: Post-operative stay ]
- Procedures per patient [ Time Frame: Interventions required to acheive duct clearance ]
- Conversion to open surgery [ Time Frame: Peri-operative ]
Original Secondary Outcome: Same as current
Information By: North Bristol NHS Trust
Dates:
Date Received: January 29, 2008
Date Started: March 2000
Date Completion:
Last Updated: January 29, 2008
Last Verified: January 2008
