Clinical trial NCT05041686: Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis, Acute
Lead sponsor: AuXin Surgery SA
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ability of the CADISS® System to dissect adherences without cutting
timeFrame: Surgery
Secondary outcomes:
measure: The facilitation of detachment with the CADISS System
timeFrame: Surgery
measure: The change of bleeding with the use of the CADISS System
timeFrame: Surgery
measure: A change of surgical complication risk
timeFrame: Surgery
measure: The capability of the CADISS System to highlight the cleavage plane
timeFrame: Surgery
measure: The ease of use of the CADISS System
timeFrame: Surgery
measure: The easiness of control of the topical application with the CADISS System
timeFrame: Surgery
measure: Adverse events
timeFrame: Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: AuXin Surgery
Study officials:
affiliation: University Hospital Erasme, Brussels, Belgium
name: Alphonse Lubansu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.