Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy (CVS-Notifier)

CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

The Critical View of Safety (CVS) is universally recommended to prevent bile duct injuries in laparoscopic cholecystectomy. However, CVS is underutilized and bile duct injuries are not decreasing. The CVS-Notifier SaMD (Software as a Medical Device) reminds surgeons to verify the CVS before dividing the cystic duct, as recommended by guidelines. It is hypothesized that this systematic and timely reminder could improve the implementation of CVS without disturbing surgical workflows.

Study Overview

• Status: Recruiting
• Conditions: Cholecystectomy, Laparoscopic
• Intervention / Treatment: Device: CVS-Notifier SaMD

Detailed Description

Laparoscopic cholecystectomy is the gold standard approach for the surgical removal of the gallbladder. However, between 0.3 and 1.5% of patients undergoing laparoscopic cholecystectomy experience a bile duct injury (BDI). This major complication translates into a threefold increase in mortality at 1 year, frequent medico-legal litigations, and an annual cost of about 1 billion dollars in the USA alone.

The visual perceptual illusion causing major BDIs can be prevented by implementing the Critical View of Safety (CVS). CVS consists of the clearance of the hepatocystic triangle from fat and connective tissue, the division of the lower part of the gallbladder from its liver bed, and ensuring that only two tubular structures-the cystic duct and the cystic artery-connected to the gallbladder are visible. Unfortunately, CVS implementation in surgical practices is as low as 9% and, in turn, BDIs do not decrease.

To improve the implementation of the CVS, multi-society consensus guidelines recommend to time-out to confirm CVS achievement before dividing cystic structures. A large quality improvement study demonstrated that a short time-out to recall CVS principles significantly increases CVS implementation rates. However, the implementation of the time-out and CVS decreases over time.

The CVS-Notifier SaMD reminds surgeons to time-out to verify the CVS before the division of the cystic duct. Such a systematic intraoperative reminder to implement best practices could help consistently perform safe laparoscopic cholecystectomies.

This first-in-human, exploratory study aims at evaluating the safety, usability, and potential impact of the CVS-Notifier SaMD in laparoscopic cholecystectomy.

The study is a single center, non-comparative, case series. Patients undergoing elective laparoscopic cholecystectomy who meet the eligibility criteria and express their consent to participate in the study will be enrolled. The CVS-Notifier SaMD will be installed on a medical grade computer connected to a secondary output of the laparoscopic video system (input) and to an auxiliary screen in the operating room (OR) (output). Surgeons will start the procedure as usual while the CVS-Notifier SaMD unobtrusively analyses the surgical video. When the beginning of the hepatocystic triangle dissection is detected, a visual reminder to verify CVS in an intraoperative time-out notification will appear on the auxiliary OR screen.

Surgeons and patients will be asked to fill in a survey to report their experience, after the procedure and before discharge, respectively.

Clinical, surgical, and device-related data will be collected and analyzed.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armelle TAKEDA, PhD; Phone Number: +33341903608; Email: armelle.takeda@ihu-strasbourg.eu

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Visceral and Digestive Surgery, Nouvel Hôpital Civil
    • Contact: Silvana PERRETTA, MD, PhD; Phone Number: +33369550531; Email: silvana.perretta@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Man or woman over 18 years old.
• Patient presenting with benign gallbladder disease requiring an elective laparoscopic cholecystectomy.
• Patient without contraindications to anaesthesia or laparoscopic cholecystectomy surgery.
• Patients capable of understanding and providing their written consent to the study.
• Patient affiliated to the French social security system.

Exclusion Criteria:

• Patients presenting with malignant gallbladder disease requiring an elective laparoscopic cholecystectomy.
• Pregnant or lactating patient.
• Patient in exclusion period (determined by a previous or a current study).
• Patient under guardianship or trusteeship.
• Patient under the protection of justice or deprived of liberty.
• Patient in situation of emergency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study	Device: CVS-Notifier SaMD; The CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of CVS-Notifier SaMD related complications	The rate of CVS-Notifier SaMD related complications defined as any complications caused directly or indirectly by the device. Postoperative complication will be classified according to the Clavien-Dindo classification (Grade 1 to Grade 5).	From the day of the procedure up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intraoperative time-out	The rate of intraoperative time-out is defined as a pause in surgical activities lasting at least 2 seconds before clipping and cutting the cystic duct or the cystic artery.	The day of the procedure
Rate of CVS implementation	The rate of implementation of the CVS will be assessed postoperatively on surgical videos	The day of the procedure
Surgeons' acceptance	Surgeons' use and acceptance of the technology will be assessed with a specifically designed survey	The day of the procedure
Patients' acceptance	Patients' acceptability and expectations on the device will be assessed with a specifically designed survey	The day of the procedure

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Collaborators: Scialytics SAS
• Investigators: Principal Investigator: Silvana PERRETTA, MD, PhD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Laparoscopic cholecystectomy; Gallbladder; CVS; BDI; Critical View of Safety; Bile Duct Injuries
• Other Study ID Numbers: 24-001

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
• product manufactured in and exported from the U.S.: No