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

AuXin Surgery

Status

Completed

Conditions

Cholecystitis, Acute

Treatments

Combination Product: CADISS® System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05041686

CADISS1703

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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