- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07507292
Cystic Artery Dissection With Dorsal Infundibular Approach Versus Critical View of Safety
March 27, 2026 updated by: Yasser Ali Orban, Zagazig University
Cystic Artery Dissection With Dorsal Infundibular Approach Versus Critical View of Safety: A Prospective Randomized Study Optimizing Outcomes in Laparoscopic Cholecystectomy
We evaluated the efficacy of combining cystic artery dissection with a dorsal infundibular approach in comparison to the critical view of safety.
By analyzing these techniques, we aim to refine laparoscopic cholecystectomy protocols and enhance patient safety by minimizing bile duct complications
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sharqia Province
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Zagazig, Sharqia Province, Egypt
- Zagazig Univeesity Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
the study included adult patients who were candidates for laparoscopic cholecystectomy.
- Exclusion criteria: patients who were unfit for surgery, patients with acute cholecystitis, and patients who refused to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: critical view of saftey
dissection was conducted to provide the critical view of safety prior to the clipping and division of the cystic duct and artery
|
Achievement of the Critical View of Safety (CVS) requires the completion of three mandatory criteria prior to the application of clips: first, the complete clearance of all fibro-fatty tissue from the hepatocystic triangle; second, the mobilization of the lower pole of the gallbladder from the liver bed to expose at least the inferior third of the cystic plate; and finally, the clear demonstration of exactly two structures-the cystic duct and cystic artery-entering the gallbladder.
Only upon definitive visualization of these components is the CVS considered achieved
|
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Experimental: cystic artery dissection with dorsal infundibular dissection (CADID)
by identification and dissection of the cystic artery along with dorsal infundibular dissection with maintaining the integrity of the hepatocystic triangle
|
Following optimized gallbladder retraction and identification of the Rouviere's sulcus, any existing adhesions were cleared via a combination of blunt and sharp dissection.
The procedure commenced with a peritoneal incision on the right lateral aspect at the cysto-infundibular junction, facilitating lateral retraction of the infundibulum and opening of the hepatocystic (Calot's) triangle.
Subsequently, the left-sided peritoneum was incised along the anterior border of the cystic artery, extending over the inferior fourth of the gallbladder.
Precise hemostasis was maintained, particularly at the ductal branches, to ensure a clear operative field.
Connecting the bilateral peritoneal incisions ventrally facilitated the creation of a retro-ductal window.
This maneuver allowed for superior retraction of the infundibulum away from the common bile duct, effectively straightening the cystic duct for safer identification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of iatrogenic bike duct unjury
Time Frame: Biliary Tract Injury will be monitored from the start of the surgical procedure through the 30-day postoperative follow-up period. This includes all intraoperative detections and any delayed presentations (leaks or strictures) confirmed via biochemical
|
Biliary Tract Injury will be monitored from the start of the surgical procedure through the 30-day postoperative follow-up period. This includes all intraoperative detections and any delayed presentations (leaks or strictures) confirmed via biochemical
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2022
Primary Completion (Actual)
December 22, 2023
Study Completion (Actual)
December 22, 2023
Study Registration Dates
First Submitted
March 27, 2026
First Submitted That Met QC Criteria
March 27, 2026
First Posted (Actual)
April 2, 2026
Study Record Updates
Last Update Posted (Actual)
April 2, 2026
Last Update Submitted That Met QC Criteria
March 27, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Cystic Artery Dissection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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