NCT00612846

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2000

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
Last Updated

February 12, 2008

Status Verified

January 1, 2008

Enrollment Period

6 years

First QC Date

January 29, 2008

Last Update Submit

January 29, 2008

Conditions

CholedocholithiasisHigher Risk Patients

Keywords

Common Bile Duct CalculiCholedocholithiasisEndoscopic sphincterotomyCholecystectomy, laparoscopicLaparoscopic bile duct exploration

Outcome Measures

Primary Outcomes (1)

  • Bile duct clearance

    Peri-operative

Secondary Outcomes (4)

  • 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

Study Arms (2)

A

EXPERIMENTAL
Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

B

EXPERIMENTAL
Procedure: Laparoscopic bile duct exploration during cholecystectomy

Interventions

Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomyPROCEDURE

Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

A
Laparoscopic bile duct exploration during cholecystectomyPROCEDURE

Laparoscopic bile duct exploration during cholecystectomy

B

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Not fit for general anaesthesia
  • Cholangitis requiring emergency ERCP
  • Previous upper GI surgery making ERCP impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CholedocholithiasisGallstones

Interventions

Sphincterotomy, Endoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeEndoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyMinimally Invasive Surgical ProceduresSphincterotomyMyotomy

Study Officials

  • Michael H Thompson, MD, FRCS

    North Bristol NHS Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 12, 2008

Study Start

March 1, 2000

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

February 12, 2008

Record last verified: 2008-01