Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00806780
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : December 11, 2008
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Common Bile Duct Stones Procedure: on table cholangiography Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is There a Role for Routine Intraoperative Cholangiography During Laparoscopic Cholecystectomy
Study Start Date : June 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
No Intervention: 1
routine surgery with cholangiography
Experimental: 2
routine cholangiography
Procedure: on table cholangiography
x-ray imaging of common bile duct

Primary Outcome Measures :
  1. incidence of stones in common bile duct [ Time Frame: at surgery ]

Secondary Outcome Measures :
  1. post-operative complications [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00806780

United Kingdom
Royal Bournemouth Hospital
Bournemouth, Hampshire, United Kingdom, BH7 7DW
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mr Balaji, Royal Bournemouth Hospital Identifier: NCT00806780     History of Changes
Other Study ID Numbers: 1209/02/E
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust: