Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients - Full Text View

Sponsored by:	North Bristol NHS Trust
Information provided by:	North Bristol NHS Trust
ClinicalTrials.gov Identifier:	NCT00612846

Purpose

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.

Condition	Intervention
Choledocholithiasis Higher Risk Patients	Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy Procedure: Laparoscopic bile duct exploration during cholecystectomy

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by North Bristol NHS Trust:

Primary Outcome Measures:

Bile duct clearance [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity and mortality [ Time Frame: 30 day or directly relating to intervention ] [ Designated as safety issue: No ]
Post-operative stay [ Time Frame: Post-operative stay ] [ Designated as safety issue: No ]
Procedures per patient [ Time Frame: Interventions required to acheive duct clearance ] [ Designated as safety issue: No ]
Conversion to open surgery [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]

Enrollment:	91
Study Start Date:	March 2000
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
B: Experimental	Procedure: Laparoscopic bile duct exploration during cholecystectomy Laparoscopic bile duct exploration during cholecystectomy

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612846

Sponsors and Collaborators

North Bristol NHS Trust

Investigators

Study Director:

Michael H Thompson, MD, FRCS

North Bristol NHS Trust

More Information

Responsible Party:	North Bristol NHS Trust ( Michael H Thompson )
Study ID Numbers:	112/99
Study First Received:	January 29, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00612846
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by North Bristol NHS Trust:

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

Study placed in the following topic categories:

Cholecystolithiasis
Cholelithiasis
Digestive System Diseases
Gallstones

Bile Duct Diseases
Biliary Tract Diseases
Calculi
Choledocholithiasis

Additional relevant MeSH terms:

Common Bile Duct Diseases

ClinicalTrials.gov processed this record on January 16, 2009