Indications under registration process
Advantages observed during the cholecystectomy clinical study
Facilitate the detachment
Reduction of dissection risk
Topical application reveals cleavage planes
Reduction of operative (e.g. bleedings) and post-operative complications
Risk of intervention reduced
Clinical trial
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. June 02,2021.
Investigators
- Dr. Malvaux, Specialist in digestive surgery, CHWAPI Union Site (Tournai) – Belgium
- Dr. Gryspeerdt, expert in complex liver and pancreatic surgery, Heilig Hart Ziekenhuis Lier – Belgium
Objective
The primary objective of this study is to evaluate the usefulness of the CADISS System for dissection of the Calot’s triangle or gallbladder during the detachment of pathological tissues in laparoscopic cholecystectomy.
Methodology
A prospective, multi-sites, open label, single cohort clinical trial on 15 patients evaluating the use of CADISS System to facilitate dissection of Calot’s triangle and gallbladder in patients who undergo a cholecystectomy in case of acute cholecystitis.
Conclusion
This study in a limited number of patients suggests that chemically assisted dissection seemed to facilitate and improve safety of dissection in acute cholecystitis. Topical deposition of a mesna solution helps reveal the anatomical planes and may reduce the use of non-selective cutting instruments such as electric knives. Benefits appeared independent from the severity grade of cholecystitis and from the delay in performing the surgery. Further studies should be conducted to confirm our preliminary results.
