Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy

A Prospective, Multi-site, Single Cohort, Non-controlled, Non-randomized Clinical Trial Evaluating the Usefulness of CADISS® System for the Cleavage of Severe Adhesions in Acute Cholecystitis (Cholecystectomy)

Acute cholecystitis is the most common complication of cholelithiasis. Acute cholecystitis is inflammation of the gallbladder that develops over hours, usually due to an obstruction of the cystic duct by a gallstone. Removal of the gallbladder (Cholecystectomy) is the only definitive treatment for acute cholecystitis, with laparoscopic cholecystectomy (LC) considered the gold standard. Serious complications that may occur with laparoscopic cholecystectomy, including bile duct injury, bile leaks, bleeding, and bowel injury, result in part from the anatomy, disease related pathology and structural misidentification due to inflammatory process (Gupta 2019).

The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments. It is based on the property of the drug mesna (Sodium 2-mercaptoethane sulfonate) to cleave the disulfide bonds responsible for the adherence of pathological tissues and for the strength of fibrosis. This study is a prospective, multi-sites, open label, single cohort clinical trial evaluating the use of CADISS® system to facilitate dissection of severe adhesions in cholecystectomy and to allow better identification of different structure.

Study Overview

• Status: Completed
• Conditions: Cholecystitis, Acute
• Intervention / Treatment: Combination product: CADISS® System

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-la-Neuve, Belgium, 1348
    • AuXin Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 18 years old
• Weight > 30 kg
• Confirmed diagnosis of acute gallstone cholecystitis
• Symptomatic or asymptomatic cholecystitis
• Under surgery for cholecystectomy:
• for the 5 first patients : cholecystectomy will take place within 72 hours of the first symptoms of cholecystitis
• after the 5 first patients : cholecystectomy will be allowed at any time after the first symptoms and at physician judgment
• Patient agrees to signed the informed consent

Exclusion Criteria:

• < 18 years old
• ≤ 30 kg
• Known hypersensibility to mesna
• Patient taking anticoagulant at the screening visit
• Patient having a pancreatitis or angiocholitis
• Patients suffering from hepatic or renal disorders
• Unable to sign the informed consent
• Participation in any study involving an investigational drug or device within the past 3 Months.
• Patient is pregnant, breastfeeding or has wish of pregnancy during the study.
• Individuals under tutorship or trusteeship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: CADISS® System

Combination product: CADISS® System; The CADISS® device was procured from AuXin Surgery. It consists in three elements: A single use disposable Remote Kit, containing a sterile cartridge, which prepares the Drug Product immediately before use, and the sterile tubing for fluid connexion. The Drug Product is a 30 ml sterile 5% mesna solution of pH 7.3+/-0.5 2.; Reusable stainless steel noncutting mechanical instruments similar to those used in the normal practice, except for the provision of an internal irrigation channel bringing the Drug Product at the working edge.; A pedal controlled electric motor driving the peristaltic cassette included in the disposable tubing in order to control the dispensing of the Drug Product during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of the CADISS® System to dissect adherences without cutting	Percentage of successful dissection	Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The facilitation of detachment with the CADISS System	Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice	Surgery
The change of bleeding with the use of the CADISS System	Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means the use of CADISS System reduction reduce bleeding compared to the current practice.	Surgery
A change of surgical complication risk	Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means the use of the CADISS System reduce the risk of surgical complication risks compared to the current practice.	Surgery
The capability of the CADISS System to highlight the cleavage plane	Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means an improvement compared to the current practice	Surgery
The ease of use of the CADISS System	Likert scale - 0 to 10, A score of 0 representing the worse outcome	Surgery
The easiness of control of the topical application with the CADISS System	Likert scale - 0 to 10, A score of 0 representing the worse outcome	Surgery
Adverse events	All CADISS® related adverse events will be reported	Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up

Collaborators and Investigators

• Sponsor: AuXin Surgery SA
• Investigators: Principal Investigator: Alphonse Lubansu, University Hospital Erasme, Brussels, Belgium

Publications and helpful links

General Publications

• Malvaux P, Gherardi D, Gryspeerdt F, De Gheldere C. The utility of the CADISS(R) system in laparoscopic cholecystectomy for acute cholecystitis. Surg Endosc. 2022 Dec;36(12):9462-9468. doi: 10.1007/s00464-022-09616-w. Epub 2022 Nov 1.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: CADISS1703

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