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

December 10, 2008
December 10, 2008
June 2003
December 2007   (final data collection date for primary outcome measure)
incidence of stones in common bile duct [ Time Frame: at surgery ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
post-operative complications [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Common Bile Duct Stones
Procedure: on table cholangiography
x-ray imaging of common bile duct
  • No Intervention: 1
    routine surgery with cholangiography
  • Experimental: 2
    routine cholangiography
    Intervention: Procedure: on table cholangiography
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00806780
1209/02/E
No
Mr Balaji, Royal Bournemouth Hospital
Royal Brompton & Harefield NHS Foundation Trust
Not Provided
Not Provided
Royal Brompton & Harefield NHS Foundation Trust
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP