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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00806780
Other study ID # 1209/02/E
Secondary ID
Status Completed
Phase N/A
First received December 10, 2008
Last updated December 10, 2008
Start date June 2003
Est. completion date December 2007

Study information

Verified date December 2008
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
on table cholangiography
x-ray imaging of common bile duct

Locations

Country Name City State
United Kingdom Royal Bournemouth Hospital Bournemouth Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of stones in common bile duct at surgery No
Secondary post-operative complications one year No
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