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

Choledocholithiasis Clinical Trial

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 Patients With Choledocholithiasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00612846
• Other study ID #: 112/99
• Status: Terminated
• Phase: N/A
• First received: January 29, 2008
• Last updated: January 29, 2008
• Start date: March 2000
• Est. completion date: March 2006

Study information

• Verified date: January 2008
• Source: North Bristol NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choledocholithiasis
• Higher Risk Patients

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Bristol NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile duct clearance		Peri-operative	No
Secondary	Morbidity and mortality		30 day or directly relating to intervention	No
Secondary	Post-operative stay		Post-operative stay	No
Secondary	Procedures per patient		Interventions required to acheive duct clearance	No
Secondary	Conversion to open surgery		Peri-operative	No