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Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103570
First Posted: April 14, 2010
Last Update Posted: April 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Theodor Bilharz Research Institute
  Purpose
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.

Condition Intervention Phase
Laparoscopic Cholecystectomy Gall Stone Disease Biliary Tract Anatomy Common Bile Duct Stones. Procedure: cholecystocholangiography Procedure: cystic duct cholangiography Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cholecystocholangiography Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy: A Prospective Controlled Randomized Trial

Further study details as provided by Theodor Bilharz Research Institute:

Primary Outcome Measures:
  • success rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • procedure-related complications [ Time Frame: 3 months ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1 cholecystocholangiography
cholangiography via gall bladder
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
Other Name: cholangiography via gallbladder
Experimental: group2 cystic duct cholangiography
cystic duct cholangiography
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.
Other Name: cholangiography via cystic dict

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103570


Locations
Egypt
Department of General Surgery * Theodore Bilharz Research Institute
Cairo, Egypt, 112124
Sponsors and Collaborators
Theodor Bilharz Research Institute
  More Information

Responsible Party: magdy elsebae, Department of General Surgery * Theodore Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT01103570     History of Changes
Other Study ID Numbers: cholangiography
First Submitted: April 9, 2010
First Posted: April 14, 2010
Last Update Posted: April 14, 2010
Last Verified: April 2010

Keywords provided by Theodor Bilharz Research Institute:
Laparoscopic cholecystectomy
Intra-operative cholangiography

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical