Endoscopic submucosal dissection using a new scissors-type electrosurgical knife: a first-in-human feasibility study

Background and study aims: Endoscopic submucosal dissection (ESD) is more difficult and has a higher rate of complications, such as perforation and bleeding, compared with conventional endoscopic resection. The aim of this study was to evaluate the feasibility of a new scissors-type electrosurgical knife for ESD, which was developed for improved durability and ease of use.

Materials and methods: Initial ex vivo experiments and subsequent ESD procedures in live pigs were carried out. A human feasibility study was then performed in patients with early esophageal or gastric cancer. The primary end point was serious adverse events (SAE) related to ESD.

Results: In the ex vivo and live animal models, no mechanical errors occurred and only minor damage to surrounding tissue was observed. Four patients were enrolled in the human feasibility study; all ESD procedures were completed with a mean procedure time of 31 minutes. All specimens were resected completely without any SAEs. The device worked smoothly, with no electrical problems noted.

Conclusion: ESD using a novel scissors-type knife for early esophageal or gastric cancer is feasible.

Clinical trial registration: UMIN000004941.

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