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
  Purpose

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


Condition Intervention
Common Bile Duct Stones
Procedure: on table cholangiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Is There a Role for Routine Intraoperative Cholangiography During Laparoscopic Cholecystectomy

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • incidence of stones in common bile duct [ Time Frame: at surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post-operative complications [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
routine surgery with cholangiography
Experimental: 2
routine cholangiography
Procedure: on table cholangiography
x-ray imaging of common bile duct

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806780

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

No publications provided by Royal Brompton & Harefield NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr Balaji, Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT00806780     History of Changes
Other Study ID Numbers: 1209/02/E
Study First Received: December 10, 2008
Last Updated: December 10, 2008
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
gallstones
cholangiography

ClinicalTrials.gov processed this record on October 23, 2014