Back to resultsCholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy
Primary Purpose
Laparoscopic Cholecystectomy, Gall Stone Disease, Biliary Tract Anatomy
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
cholecystocholangiography
cystic duct cholangiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Laparoscopic Cholecystectomy focused on measuring Laparoscopic cholecystectomy, Intra-operative cholangiography
Eligibility 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
Sites / Locations
- Department of General Surgery * Theodore Bilharz Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1 cholecystocholangiography
group2 cystic duct cholangiography
Arm Description
cholangiography via gall bladder
cystic duct cholangiography
Outcomes
Primary Outcome Measures
success rate
Secondary Outcome Measures
procedure-related complications
Full Information
NCT ID
NCT01103570
First Posted
April 9, 2010
Last Updated
April 13, 2010
Sponsor
Theodor Bilharz Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01103570
Brief Title
Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy
Official Title
Cholecystocholangiography Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy: A Prospective Controlled Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Theodor Bilharz Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy, Gall Stone Disease, Biliary Tract Anatomy, Common Bile Duct Stones.
Keywords
Laparoscopic cholecystectomy, Intra-operative cholangiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1 cholecystocholangiography
Arm Type
Experimental
Arm Description
cholangiography via gall bladder
Arm Title
group2 cystic duct cholangiography
Arm Type
Experimental
Arm Description
cystic duct cholangiography
Intervention Type
Procedure
Intervention Name(s)
cholecystocholangiography
Other Intervention Name(s)
cholangiography via gallbladder
Intervention Description
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
Intervention Name(s)
cystic duct cholangiography
Other Intervention Name(s)
cholangiography via cystic dict
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
procedure-related complications
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of General Surgery * Theodore Bilharz Research Institute
City
Cairo
ZIP/Postal Code
112124
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy
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