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

A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patients With Choledocholithiasis

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00612846

Enrollment

Registered

2008-02-12

Start date

2000-03-31

Completion date

2006-03-31

Last updated

2008-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis, Higher Risk Patients

Keywords

Common Bile Duct Calculi, Choledocholithiasis, Endoscopic sphincterotomy, Cholecystectomy, laparoscopic, Laparoscopic bile duct exploration

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.

Interventions

PROCEDUREEndoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

PROCEDURELaparoscopic bile duct exploration during cholecystectomy

Laparoscopic bile duct exploration during cholecystectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Bile duct clearance	Peri-operative

Secondary

Measure	Time frame
Morbidity and mortality	30 day or directly relating to intervention
Post-operative stay	Post-operative stay
Procedures per patient	Interventions required to acheive duct clearance
Conversion to open surgery	Peri-operative

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026