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

NCT00612846 — Not applicable, Terminated, 91 participants, North Bristol NHS Trust
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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

RegistryNCT00612846
StatusTerminated - Terminated early due to slow recruitment
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment91 (Actual)
SponsorNorth Bristol NHS Trust (Other)
ConditionsCholedocholithiasis, Higher Risk Patients
InterventionsEndoscopic sphincterotomy and subsequent laparoscopic cholecystectomy, Laparoscopic bile duct exploration during cholecystectomy (Procedure)
Datesstart 2000-03-01, primary completion 2006-03-01, completion 2006-03-01, first posted 2008-02-12, last updated 2008-02-12

Related Papers Related Patents Related Grants Related Experts
All trials for Choledocholithiasis All trials for Higher Risk Patients All trials of Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy All trials of Laparoscopic bile duct exploration during cholecystectomy

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
AExperimentalProcedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
BExperimentalProcedure: Laparoscopic bile duct exploration during cholecystectomy
  • Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy (Procedure): Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
  • Laparoscopic bile duct exploration during cholecystectomy (Procedure): Laparoscopic bile duct exploration during cholecystectomy

+Outcome measures

Primary outcomes

  • Bile duct clearance [Peri-operative]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 50 Years to any

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

+Investigators