Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy

NCT ID: NCT01103570

Last Updated: 2010-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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group 1 cholecystocholangiography

cholangiography via gall bladder

Group Type EXPERIMENTAL

cholecystocholangiography

Intervention Type 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

group2 cystic duct cholangiography

cystic duct cholangiography

Group Type EXPERIMENTAL

cystic duct cholangiography

Intervention Type 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.

Interventions

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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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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cholangiography via gallbladder cholangiography via cystic dict

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theodor Bilharz Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Department of General Surgery * Theodore Bilharz Research Institute

Locations

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Department of General Surgery * Theodore Bilharz Research Institute

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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cholangiography

Identifier Type: -

Identifier Source: org_study_id

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