Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy

NCT ID: NCT00806780

Last Updated: 2008-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Common Bile Duct Stones

Keywords

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gallstones cholangiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

routine surgery with cholangiography

Group Type NO_INTERVENTION

No interventions assigned to this group

2

routine cholangiography

Group Type EXPERIMENTAL

on table cholangiography

Intervention Type PROCEDURE

x-ray imaging of common bile duct

Interventions

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on table cholangiography

x-ray imaging of common bile duct

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Bournemouth Hospital

Locations

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Royal Bournemouth Hospital

Bournemouth, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 21254008 (View on PubMed)

Other Identifiers

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1209/02/E

Identifier Type: -

Identifier Source: org_study_id