FTRD System, Ovesco Endoscopy AG

gastroduodenal FTRD®: Full-thickness resection of gastric SETs enables definitive histological diagnosis, better than conventional biopsy

Gastric EFTR in 29 patients with gastric SET led to en-bloc resection in 89.7 %, 76 % R0 resection and final histological diagnosis in all resected specimens. The only periprocedural complication of minor bleeding was managed endoscopically in all cases.

Dr B. Meier et al.., Department of Gastroenterology, Ludwigsburg Hospital, Ludwigsburg, Germany, initiated the RESET trial in March 2017, a prospective observational multicenter pilot trial evaluating efficacy and safety of clip-assisted endoscopic full-thickness resection (EFTR) for gastric subepithelial tumors (SET). Gastric SET up to 15 mm were included in the trial. Primary endpoint was complete en-bloc resection. Secondary endpoints were R0 resection, full-thickness resection, adverse events and recurrence rate at 3-months follow-up.

29 patients underwent gastric EFTR. Histology after conventional biopsy prior to EFTR was only able to define histological tumor type in 31.2 %. Complete en-bloc resection with the gFTRD System was achieved in 89.7 %. Histology of the specimen defined the histological tumor type in 100 %. 76 % of all SET was resected histologically complete (R0), requiring no further diagnostic intervention; full-thickness-resection specimens were obtained in 65.5 %. In the remaining cases resection reached deep into the wall. In 31 % minor bleeding was observed and managed endoscopically in the same session. Follow-up was available in 79.3 % and showed OTSC clip detachment in 78.3 % and the OTSC clip in position in 21.7 %. No signs of residual or recurrent tumors were observed after 3 months.

The authors concluded that EFTR of gastric SET with the gFTRD is safe and effective. It provides a definitive diagnosis (including sufficient risk stratification in case of GIST or NET) in contrast to conventional biopsy. R0 resection is achieved in most cases and might obviate the need for further surveillance endoscopies.

Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial).
Meier B, Schmidt A, Glaser N, Meining A, Walter B, Wannhoff A, Riecken B, Caca K.
Surgical Endoscopy https://doi.org/10.1007/s00464-019-06839-2