Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy

NCT01103570 | Completed Phase 4 DMC

• 1 other identifier: cholangiography
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be difficult, time consuming and bile duct injury may be caused by attempts to cannulate the cystic duct. Operative cholangiography performed by direct puncture of the gall bladder fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.

Conditions

Laparoscopic Cholecystectomy; Gall Stone Disease; Biliary Tract Anatomy; Common Bile Duct Stones.

Keywords

Laparoscopic cholecystectomy; Intra-operative cholangiography

Outcome Measures

Primary Outcomes (1)

• success rate

  6 months

Secondary Outcomes (1)

• procedure-related complications

  3 months

Study Arms (2)

group 1 cholecystocholangiography

EXPERIMENTAL

cholangiography via gall bladder

Procedure: cholecystocholangiography

group2 cystic duct cholangiography

EXPERIMENTAL

cystic duct cholangiography

Procedure: cystic duct cholangiography

Interventions

cholecystocholangiography PROCEDURE

a central venous pressure catheter was introduced through the anterior abdominal wall subcostally in a direction parallel to the gallbladder bed under direct vision so that it emerges close to the gall bladder. Then the catheter was advanced into the fundus of the gall bladder . The dye was prepared by diluting 20ml of 76% urografin with 20ml normal saline in a 50ml syringe

Also known as: cholangiography via gallbladder

group 1 cholecystocholangiography

cystic duct cholangiography PROCEDURE

Then a 14G cannula was introduced through the anterior abdominal wall subcostally, (size 4F), was introduced through this cannula. The catheter was inserted into the cystic duct no more than 1 cm, by a grasper Then a 50ml syringe with the diluted urografin dye, as above, was attached to the catheter and cholangiography was performed by slowly injecting the dye under control of C-arm image intensifier.

Also known as: cholangiography via cystic dict

group2 cystic duct cholangiography

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with symptomatic gall bladder stones.

You may not qualify if:

• unfit Patients and/or had previous surgery
• history of obstructive jaundice and acute attacks or previous ERCP were excluded

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Department of General Surgery * Theodore Bilharz Research Institute

Cairo, 112124, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 14, 2010
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 14, 2010

Record last verified: 2010-04

Locations

EG (1)