Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients

NHS Trust

Status: Terminated

Conditions: Higher Risk Patients; Choledocholithiasis

Treatments: Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy; Procedure: Laparoscopic bile duct exploration during cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00612846

112/99

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gallbladder stones
• At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
• Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40)

Exclusion criteria

• Not fit for general anaesthesia
• Cholangitis requiring emergency ERCP
• Previous upper GI surgery making ERCP impossible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

91 participants in 2 patient groups

A

Experimental group

Treatment:

Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

B

Experimental group

Treatment:

Procedure: Laparoscopic bile duct exploration during cholecystectomy