Laparoscopic Cholecystectomy SurgeryNCT07507292
Cystic Artery Dissection With Dorsal Infundibular Approach Versus Critical View of Safety
A study testing critical view of saftey and cystic artery dissection with dorsal infundibular dissection in people with Laparoscopic Cholecystectomy Surgery, run by Zagazig University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery
- What is being tested?
- critical view of saftey and cystic artery dissection with dorsal infundibular dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Dec 2022to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Being tested
- critical view of saftey, cystic artery dissection with dorsal infundibular dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
critical view of safteyProcedure or surgery
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
cystic artery dissection with dorsal infundibular dissectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: cystic artery dissection with dorsal infundibular dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of iatrogenic bike duct unjury
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start22 Dec 2022
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yasser Ali Orban, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507292
- Sponsor's protocol ID
- Cystic Artery Dissection
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystic Artery Dissection With Dorsal Infundibular Approach Versus Critical View of Safety: A Prospective Randomized Study Optimizing Outcomes in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07507292
- Acronym / sponsor ID
- Cystic Artery Dissection
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| critical view of saftey | Active comparator | Procedure: critical view of safteydissection was conducted to provide the critical view of safety prior to the clipping and division of the cystic duct and artery |
| cystic artery dissection with dorsal infundibular dissection (CADID) | Experimental | Procedure: cystic artery dissection with dorsal infundibular dissectionby identification and dissection of the cystic artery along with dorsal infundibular dissection with maintaining the integrity of the hepatocystic triangle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| critical view of safteyAchievement 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 | Procedure or surgery | critical view of saftey |
| cystic artery dissection with dorsal infundibular dissectionFollowing 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 | Procedure or surgery | cystic artery dissection with dorsal infundibular dissection (CADID) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing critical view of saftey and cystic artery dissection with dorsal infundibular dissection in people with Laparoscopic Cholecystectomy Surgery, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.