Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy
December 10, 2008 updated by: Royal Brompton & Harefield NHS Foundation Trust
Is There a Role for Routine Intraoperative Cholangiography During Laparoscopic Cholecystectomy
The purpose of this study is to assess whether routine imaging of the biliary system during routine gallbladder surgery alters clinical outcome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hampshire
-
Bournemouth, Hampshire, United Kingdom, BH7 7DW
- Royal Bournemouth Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 1
routine surgery with cholangiography
|
|
|
Experimental: 2
routine cholangiography
|
x-ray imaging of common bile duct
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence of stones in common bile duct
Time Frame: at surgery
|
at surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
post-operative complications
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
December 10, 2008
First Submitted That Met QC Criteria
December 10, 2008
First Posted (Estimate)
December 11, 2008
Study Record Updates
Last Update Posted (Estimate)
December 11, 2008
Last Update Submitted That Met QC Criteria
December 10, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1209/02/E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.