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.