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

North Bristol NHS Trust91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Choledocholithiasis Higher Risk Patients

Interventions

Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomyPROCEDURE

Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

Laparoscopic bile duct exploration during cholecystectomyPROCEDURE

Laparoscopic bile duct exploration during cholecystectomy

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bile duct clearance

Time frame: Peri-operative

Secondary Outcomes

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

Data from ClinicalTrials.gov

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