NCT07507292

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 27, 2026

Last Update Submit

March 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of iatrogenic bike duct unjury

    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

Study Arms (2)

critical view of saftey

ACTIVE COMPARATOR

dissection was conducted to provide the critical view of safety prior to the clipping and division of the cystic duct and artery

Procedure: critical view of saftey

cystic artery dissection with dorsal infundibular dissection (CADID)

EXPERIMENTAL

by identification and dissection of the cystic artery along with dorsal infundibular dissection with maintaining the integrity of the hepatocystic triangle

Procedure: cystic artery dissection with dorsal infundibular dissection

Interventions

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

critical view of saftey

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

cystic artery dissection with dorsal infundibular dissection (CADID)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the study included adult patients who were candidates for laparoscopic cholecystectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig Univeesity Hospitals

Zagazig, Sharqia Province, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

December 22, 2022

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations