Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy

This study has been completed.

Sponsor:

Information provided by:

Royal Brompton & Harefield NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT00806780

First received: December 10, 2008

Last updated: NA

Last verified: December 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 10, 2008
Last Updated Date	December 10, 2008
Start Date ^ICMJE	June 2003
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 10, 2008)	incidence of stones in common bile duct [ Time Frame: at surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: December 10, 2008)	post-operative complications [ Time Frame: one year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy
Official Title ^ICMJE	Is There a Role for Routine Intraoperative Cholangiography During Laparoscopic Cholecystectomy
Brief Summary	The purpose of this study is to assess whether routine imaging of the biliary system during routine gallbladder surgery alters clinical outcome
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Common Bile Duct Stones
Intervention ^ICMJE	Procedure: on table cholangiography x-ray imaging of common bile duct
Study Arm (s)	No Intervention: 1 routine surgery with cholangiography Experimental: 2 routine cholangiography Intervention: Procedure: on table cholangiography
Publications *	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. Epub 2010 Nov 24.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	200
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00806780
Other Study ID Numbers ^ICMJE	1209/02/E
Has Data Monitoring Committee	No
Responsible Party	Mr Balaji, Royal Bournemouth Hospital
Study Sponsor ^ICMJE	Royal Brompton & Harefield NHS Foundation Trust
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Royal Brompton & Harefield NHS Foundation Trust
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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