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

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Abstract

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.

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Acknowledgements

We thank Ovesco Endoscopy for the financial and technical support during the study.

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Authors and Affiliations

  1. Department of Gastroenterology, Klinikum Ludwigsburg, Posilipostraße 4, 71640, Ludwigsburg, Germany

    Benjamin Meier, Andreas Wannhoff, Bettina Riecken & Karel Caca

  2. Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany

    Arthur Schmidt & Nicolas Glaser

  3. Department of Gastroenterology, University Hospital Ulm, Ulm, Germany

    Alexander Meining & Benjamin Walter

Authors
  1. Benjamin Meier
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  2. Arthur Schmidt
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  3. Nicolas Glaser
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  4. Alexander Meining
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  5. Benjamin Walter
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  6. Andreas Wannhoff
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  7. Bettina Riecken
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Corresponding author

Correspondence to Karel Caca.

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Disclosures

Alexander Meining is a consultant for Ovesco Endoscopy. Karel Caca and Arthur Schmidt have received lecture fees from Ovesco Endoscopy for FTRD training courses. Benjamin Meier, Nicolas Glaser, Benjamin Walter, Bettina Riecken and Andreas Wannhoff have no conflicts of interest or financial ties to disclose.

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Meier, B., Schmidt, A., Glaser, N. et al. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc 34, 853–860 (2020). https://doi.org/10.1007/s00464-019-06839-2

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  • DOI: https://doi.org/10.1007/s00464-019-06839-2

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