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

  • Benjamin Meier
  • Arthur Schmidt
  • Nicolas Glaser
  • Alexander Meining
  • Benjamin Walter
  • Andreas Wannhoff
  • Bettina Riecken
  • Karel CacaEmail author
Article

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.

Keywords

Gastric subepithelial tumor Endoscopic full-thickness-resection FTRD gFTRD 

Notes

Acknowledgements

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

Compliance with ethical standards

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.

Supplementary material

Supplementary material 1 (WMV 42427 kb)

References

  1. 1.
    Kim GH (2012) Endoscopic resection of subepithelial tumors. Clin Endosc 45(3):240–244CrossRefGoogle Scholar
  2. 2.
    Polkowski M (2005) Endoscopic ultrasound and endoscopic ultrasound-guided fine-needle biopsy for the diagnosis of malignant submucosal tumors. Endoscopy 37(7):635–645CrossRefGoogle Scholar
  3. 3.
    Hwang JH, Rulyak SD, Kimmey MB (2006) American Gastroenterological Association Institute technical review on the management of gastric subepithelial masses. Gastroenterology 130(7):2217–2228CrossRefGoogle Scholar
  4. 4.
    Faigel DO, Abulhawa S (2012) Gastrointestinal stromal tumors: the role of the gastroenterologist in diagnosis and risk stratification. J Clin Gastroenterol 46(8):629–636CrossRefGoogle Scholar
  5. 5.
    Lim TW, Choi CW, Kang DH, Kim HW, Park SB, Kim SJ (2016) Endoscopic ultrasound without tissue acquisition has poor accuracy for diagnosing gastric subepithelial tumors. Medicine (Baltimore) 95(44):e5246CrossRefGoogle Scholar
  6. 6.
    Mullady DK, Tan BR (2013) A multidisciplinary approach to the diagnosis and treatment of gastrointestinal stromal tumor. J Clin Gastroenterol 47(7):578–585CrossRefGoogle Scholar
  7. 7.
    Eckardt AJ, Adler A, Gomes EM et al (2012) Endosonographic large-bore biopsy of gastric subepithelial tumors: a prospective multicenter study. Eur J Gastroenterol Hepatol 24(10):1135–1144CrossRefGoogle Scholar
  8. 8.
    Schmidt A, Beyna T, Schumacher B et al (2018) Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut 67(7):1280–1289CrossRefGoogle Scholar
  9. 9.
    Coffin CM, Hornick JL, Fletcher CD (2007) Inflammatory myofibroblastic tumor: comparison of clinicopathologic, histologic, and immunohistochemical features including ALK expression in atypical and aggressive cases. Am J Surg Pathol 31(4):509–520CrossRefGoogle Scholar
  10. 10.
    Antonini F, Delconte G, Fuccio L et al (2018) EUS-guided tissue sampling with a 20-gauge core biopsy needle for the characterization of gastrointestinal subepithelial lesions: a multicenter study. Endosc Ultrasound 8(2):105–110CrossRefGoogle Scholar
  11. 11.
    Kim JH, Chung JW, Ha M et al (2013) A feasible modified biopsy method for tissue diagnosis of gastric subepithelial tumors. World J Gastroenterol 19(29):4752–4757CrossRefGoogle Scholar
  12. 12.
    Kim JS, Kim BW, Kim GJ et al (2016) Diagnostic yield of endoscopic ultrasonography-guided single-incision needle knife biopsy for gastric subepithelial tumors: comparison with resected specimens. Surg Endosc 30(12):5304–5309CrossRefGoogle Scholar
  13. 13.
    Choi CW, Kang DH, Kim HW et al (2017) Direct endoscopic biopsy for subepithelial tumor larger than 20 mm after removal of overlying mucosa. Scand J Gastroenterol 52(6–7):779–783CrossRefGoogle Scholar
  14. 14.
    Shin SY, Lee SJ, Jun JH et al (2017) Mucosal incision and forceps biopsy for reliable tissue sampling of gastric subepithelial tumors. Clin Endosc 50(1):64–68CrossRefGoogle Scholar
  15. 15.
    Chun SY, Kim KO, Park DS et al (2013) Endoscopic submucosal dissection as a treatment for gastric subepithelial tumors that originate from the muscularis propria layer: a preliminary analysis of appropriate indications. Surg Endosc 27(9):3271–3279CrossRefGoogle Scholar
  16. 16.
    He Z, Sun C, Wang J et al (2013) Efficacy and safety of endoscopic submucosal dissection in treating gastric subepithelial tumors originating in the muscularis propria layer: a single-center study of 144 cases. Scand J Gastroenterol 48(12):1466–1473CrossRefGoogle Scholar
  17. 17.
    Guo J, Liu Z, Sun S et al (2015) Endoscopic full-thickness resection with defect closure using an over-the-scope clip for gastric subepithelial tumors originating from the muscularis propria. SurgEndosc 29(11):3356–3362Google Scholar
  18. 18.
    Shi Q, Chen T, Zhong YS et al (2013) Complete closure of large gastric defects after endoscopic full-thickness resection, using endoloop and metallic clip interrupted suture. Endoscopy 45(5):329–334CrossRefGoogle Scholar
  19. 19.
    Zhou PH, Yao LQ, Qin XY et al (2011) Endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors originated from the muscularis propria. Surg Endosc 25(9):2926–2931CrossRefGoogle Scholar
  20. 20.
    Schmidt A, Bauder M, Riecken B, von Renteln D, Muehleisen H, Caca K (2015) Endoscopic full-thickness resection of gastric subepithelial tumors: a single-center series. Endoscopy 47(2):154–158Google Scholar
  21. 21.
    Kappelle WFW, Backes Y, Valk GD, Moons LMG, Vleggaar FP (2018) Endoscopic full-thickness resection of gastric and duodenal subepithelial lesions using a new, flat-based over-the-scope clip. Surg Endosc 32(6):2839–2846CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Benjamin Meier
    • 1
  • Arthur Schmidt
    • 2
  • Nicolas Glaser
    • 2
  • Alexander Meining
    • 3
  • Benjamin Walter
    • 3
  • Andreas Wannhoff
    • 1
  • Bettina Riecken
    • 1
  • Karel Caca
    • 1
    Email author
  1. 1.Department of GastroenterologyKlinikum LudwigsburgLudwigsburgGermany
  2. 2.Department of Medicine II, Medical CenterUniversity of Freiburg, Faculty of MedicineFreiburgGermany
  3. 3.Department of GastroenterologyUniversity Hospital UlmUlmGermany

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