Clinical safety of a novel over-the-scope gastroduodenal full-thickness resection device for the treatment of upper GI tract lesions: a multicenter experience

Background and Aims

A novel gastroduodenal full-thickness resection device system was developed for resection of upper GI tract lesions. In this study, we evaluated the efficacy and safety of the gastroduodenal full-thickness resection device system.

Methods

Consecutive patients who received endoscopic resection of upper GI tract lesions from June 2020 to August 2022 using a gastroduodenal full-thickness resection device were evaluated from 8 U.S. centers. Primary endpoints were technical success and R0 resection. Secondary endpoints were en bloc resection, residual lesions at follow-up endoscopy, and immediate or delayed adverse events.

Results

Forty-four patients (mean age, 60.9 ± 15.8 years) received 45 resections for gastric (35, 80%) and duodenal (9, 20%) lesions. Thirty-four lesions (77%) were subepithelial and 10 (23%) were epithelial lesions. Technical success and en bloc resection were achieved in 43 (96%) and 41 (91%) patients, respectively. Furthermore, R0 resection was achieved in 32 patients (71%), including 24 of 35 (69%) with neoplastic lesions. Pathologic diagnosis included neuroendocrine tumor in 14 patients (32%), GI stromal tumor in 10 (23%), and gastric cancer or high-grade dysplasia in 7 (16%). Minor immediate and delayed bleeding occurred in 17 (38%) and 2 (4%) patients, respectively. One patient had delayed perforation, managed conservatively. On follow-up, 19 of 21 patients (90%) had no residual lesion.

Conclusions

In this multicenter series, the gastroduodenal full-thickness resection device demonstrated high rates of technical success and acceptable rate of R0 resection. Immediate minor bleeding was common, whereas serious adverse events were rare. This gastroduodenal full-thickness resection device should be considered in patients with gastroduodenal subepithelial lesions as an alternative to long-term surveillance.