Role of Routine on-Table Cholangiography in Laparoscopic... | NCT00806780

Studies
Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy

NCT00806780

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Status

Completed

Last Update Posted

Dec 11, 2008Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Common Bile Duct Stones

Interventions

on table cholangiography

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 10, 2008

First Submission Date that Met QC Criteria

Dec 10, 2008

First Posted Date

Dec 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2008

Last Update Posted Date

Dec 11, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	routine surgery with cholangiography
2	Experimental	routine cholangiography	Procedure: on table cholangiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
on table cholangiography	Procedure	x-ray imaging of common bile duct	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of stones in common bile duct		at surgery

Secondary Outcomes

Measure	Description	Time Frame
post-operative complications		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Bournemouth Hospital		Bournemouth	Hampshire	BH7 7DW	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21254008	Derived	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.

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis