Abstract
Background
The CADISS® system combines the use of a topical formulation of mesna (sodium 2-Mercaptoethane sulfonate) to facilitate selective dissection of pathological and fibrotic tissues with a non-cutting instrument for a safer dissection. A prospective, multi-site, clinical trial was performed to explore the use of the CADISS® system in laparoscopic cholecystectomy for acute cholecystitis.
Methods
A total of 15 patients were enrolled at different severity stages of pathology according to Tokyo classification. They were operated on prior to, or after 72 h of, the onset of symptoms. The primary measure was the number of critical dissection steps successfully achieved using the CADISS® system without cutting instruments.
Results
Five patients were operated on before 72 h of symptom onset and ten after. All the dissections were successfully achieved using the CADISS® method. No mortality was recorded. No conversion to open surgery was performed. No bile duct injury was observed. Other endpoints (facilitation of dissection of critical structures, identification of cleavage planes and reduction of risk) had scores of above nine on our Likert scale. Four postoperative serious adverse events including cholangitis, fever, pulmonary embolism and right hepatic artery pseudoaneurysm were reported. However, they seemed to be more related to cholecystitis or local conditions rather than the use of the CADISS® method.
Conclusion
This is the first study to investigate the use of the CADISS® System in cholecystectomy. The CADISS® system seemed to facilitate dissection in acute cholecystitis. Encouraging results are reported independently of the severity grade of cholecystitis and the delay in performing the surgery. Even now, laparoscopic cholecystectomy for acute cholecystitis remains a surgical challenge. Techniques that could facilitate this operation and reduce surgical complications may be helpful. Further studies should be conducted to confirm our preliminary results.
Trial registration Clinical trials.gov NCT05041686.
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The study was sponsored by Auxin Surgery s.a.
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Philippe Malvaux is a consultant for AuXin Surgery. Filip Gryspeert, Dario Gherardi and Charles de Gheldere have no conflicts of interest or financial ties to disclose.
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Malvaux, P., Gherardi, D., Gryspeerdt, F. et al. The utility of the CADISS® system in laparoscopic cholecystectomy for acute cholecystitis. Surg Endosc 36, 9462–9468 (2022). https://doi.org/10.1007/s00464-022-09616-w
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DOI: https://doi.org/10.1007/s00464-022-09616-w