Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial)

Background Gastric subepithelial tumors (SET) are rare and usually benign. However, up to 13% are malignant. Histology after conventional biopsy often is inconclusive. Surveillance endoscopies are the consequence in the majority of gastric SET cases. For SET arising from deeper layers endoscopic resection (ER) with the standard techniques is difficult and associated with the risk of perforation. The RESET trial further evaluates feasibility, efficacy and safety of clip-assisted endoscopic full-thickness resection (EFTR) for gastric SET using the novel gastric full-thickness-resection device (gFTRD). Materials and methods The RESET trial was initiated in March 2017 (NCT03096236) and designed as prospective observational multicenter pilot trial. Gastric SET up to 15 mm were included. Primary endpoint was technical success (complete enbloc resection). Secondary endpoints were R0 resection, full-thickness resection, adverse events and recurrency at 3-months follow-up. For resection we used the gFTRD (Ovesco Endoscopy, Tübingen, Germany). Results 29 patients underwent gastric EFTR. Histology prior EFTR after conventional biopsy could define histological tumor type in only 31.2%. Primary endpoint was reached in 89.7%. Histology of the full-thickness-resection specimen could define histological tumor type in 100%. 76% of all SET could be resected histologically complete (R0) and a full-thickness-resection specimen could be obtained in 65.5%. In 31% periprocedural minor bleeding was observed and managed endoscopically. Follow-up was available in 79.3% (OTSC detachment in 78.3%, OTSC in position in 21.7%). No signs of residual or recurrent tumors were observed after 3 months. Conclusion EFTR of gastric SET with gFTRD is feasible and safe. EFTR allows a definite histological diagnosis (including sufficient risk stratification in case of GIST or NET) in contrast to conventional biopsy. R0-resection is possible in most cases and might obviate the need for further surveillance endoscopies for selected patients.