Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Cholecystocholangiography Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy: A Prospective Controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103570
• Other study ID #: cholangiography
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2010
• Last updated: April 13, 2010
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Theodor Bilharz Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study was conducted on 60 patients with symptomatic gall bladder stones undergoing laparoscopic cholecystectomy. Patients were randomized into two groups: Group (1) was evaluated by cholecyst-cholangiography by puncture through the gall bladder fundus. Group (2) was evaluated for the standard cystic duct cholangiography.Cholangiography was considered successful if it could be performed with complete delineation of the biliary tree with flow of the dye through the duodenum occurred. It is to be noted that inability to cannulate the cystic duct for example, is considered a failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• patients with symptomatic gall bladder stones.

Exclusion Criteria:

• unfit Patients and/or had previous surgery

• history of obstructive jaundice and acute attacks or previous ERCP were excluded

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biliary Tract Anatomy
• Cholecystolithiasis
• Cholelithiasis
• Common Bile Duct Stones.
• Gall Stone Disease
• Gallstones
• Laparoscopic Cholecystectomy

Intervention

Procedure:
• cholecystocholangiography
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
• cystic duct cholangiography
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.

Locations

Country	Name	City	State
Egypt	Department of General Surgery * Theodore Bilharz Research Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate		6 months	Yes
Secondary	procedure-related complications		3 months	Yes