NCT00806780

Brief Summary

The purpose of this study is to assess whether routine imaging of the biliary system during routine gallbladder surgery alters clinical outcome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
Last Updated

December 11, 2008

Status Verified

December 1, 2008

Enrollment Period

4.5 years

First QC Date

December 10, 2008

Last Update Submit

December 10, 2008

Conditions

Common Bile Duct Stones

Keywords

gallstonescholangiography

Outcome Measures

Primary Outcomes (1)

  • incidence of stones in common bile duct

    at surgery

Secondary Outcomes (1)

  • post-operative complications

    one year

Study Arms (2)

1

NO INTERVENTION

routine surgery with cholangiography

2

EXPERIMENTAL

routine cholangiography

Procedure: on table cholangiography

Interventions

on table cholangiographyPROCEDURE

x-ray imaging of common bile duct

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients over the age of 18 with biliary colic or cholecystitis

You may not qualify if:

  • any history of allergic reaction to contrast material
  • patients with abnormal liver function test results
  • any clinical history of jaundice
  • patients with a history of pancreatitis
  • patients with a history of previous ERCP
  • patients whose ultrasound showed common bile duct or intra-hepatic duct dilation
  • all patients with previous major upper abdominal surgery
  • all patients with acalculous cholecystitis or gallbladder polyps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Hampshire, BH7 7DW, United Kingdom

Location

Related Publications (1)

  • Khan OA, Balaji S, Branagan G, Bennett DH, Davies N. Randomized clinical trial of routine on-table cholangiography during laparoscopic cholecystectomy. Br J Surg. 2011 Mar;98(3):362-7. doi: 10.1002/bjs.7356. Epub 2010 Nov 24.

    PMID: 21254008DERIVED

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

June 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 11, 2008

Record last verified: 2008-12

Locations

GB(1)