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

This study has been terminated.
(Terminated early due to slow recruitment)
Sponsor:
Information provided by:
North Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT00612846
First received: January 29, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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
Experimental: A Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
Experimental: B 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

No publications provided

Responsible Party: Michael H Thompson, North Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT00612846     History of Changes
Other Study ID Numbers: 112/99
Study First Received: January 29, 2008
Last Updated: January 29, 2008
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

Additional relevant MeSH terms:
Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
 Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis

ClinicalTrials.gov processed this record on May 16, 2013