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NCT Number: NCT01103570

Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of General Surgery * Theodore Bilharz Research Institute

Cairo, 112124, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: cholangiography via gallbladder

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.

Other names: cholangiography via cystic dict

Primary outcomes

  1. success rate

    Time frame: 6 months

Secondary outcomes

  1. procedure-related complications

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 14, 2010
Registry last updated
Apr 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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