Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Common Bile Duct Stones

Treatments: Procedure: on table cholangiography

Study type: Interventional

Funder types: Other

Identifiers

NCT00806780

1209/02/E

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1

No Intervention group

Description:

routine surgery with cholangiography

2

Experimental group

Description:

routine cholangiography

Treatment:

Procedure: on table cholangiography