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TerminatedNCT00612846Updated Feb 12, 2008

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

An interventional study of Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy and Laparoscopic bile duct exploration during cholecystectomy in Choledocholithiasis and Higher Risk Patients, sponsored by North Bristol NHS Trust. Terminated. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2008-02-12.

Sponsored by North Bristol NHS Trust · Not applicable, Interventional, and Treatment

Why this study was terminated
Terminated early due to slow recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Choledocholithiasis
  • Higher Risk Patients

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Keywords

  • Common Bile Duct Calculi
  • Choledocholithiasis
  • Endoscopic sphincterotomy
  • Cholecystectomy, laparoscopic
  • Laparoscopic bile duct exploration
03

In context

Choledocholithiasis

104 studies on the registry are indexed under Choledocholithiasis; 23 are open to participants now.

This study's enrollment of 91 is below the median of 108 across 70 interventional studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

North Bristol NHS Trust is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Not fit for general anaesthesia
  • Cholangitis requiring emergency ERCP
  • Previous upper GI surgery making ERCP impossible
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    A

    Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

  • Experimental
    B

    Procedure: Laparoscopic bile duct exploration during cholecystectomy

Interventions

  • ProcedureEndoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

    Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

  • ProcedureLaparoscopic bile duct exploration during cholecystectomy

    Laparoscopic bile duct exploration during cholecystectomy

06

What researchers measure

Primary outcomes

  1. Bile duct clearance

    Time frame: Peri-operative

Secondary outcomes

  1. Morbidity and mortality

    Time frame: 30 day or directly relating to intervention

  2. Post-operative stay

    Time frame: Post-operative stay

  3. Procedures per patient

    Time frame: Interventions required to acheive duct clearance

  4. Conversion to open surgery

    Time frame: Peri-operative

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00612846
Lead sponsor
North Bristol NHS Trust
First posted
Feb 12, 2008
Start date
Mar 2000
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Feb 12, 2008

Study contacts

Michael H Thompson, MD, FRCS
study director · North Bristol NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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