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Feasibility of pure EFTR using an innovative new endoscopic suturing device: the Double-arm-bar Suturing System (with video)

Abstract

Background

Endoscopic full-thickness resection (EFTR) requires a reliable full-thickness suturing device and an endoscopic counter-traction device to prevent the collapse of the digestive tract.

Objective

The present study aimed to assess the reliability of newly developed flexible endoscopy suturing devices and the feasibility of pure EFTR.

Methods

A total of 30 EFTRs were performed and allocated to three groups (N = 10 for each group). The full-thickness sutures were placed using over-the-scope clips (OTSCs), hand-sewn sutures, or the Double-arm-bar Suturing System (DBSS). Air leak tests were conducted in the three groups. The times required for the placement of one OTSC suture and single-stitch simple interrupted sutures (hand-sewn and DBSS sutures, respectively) were also compared.

Results

All 30 full-thickness sutures were completely and successfully placed. Regarding the air leak tests, the Mann–Whitney U test showed significant differences between OTSC and hand-sewn sutures (p = 0.003). There was also a significant difference between OTSC and DBSS sutures (p = 0.023). There was no significant difference between hand-sewn and DBSS sutures (p = 0.542). A significant difference was found in the suture time for single-stitch simple interrupted sutures among the OTSC, hand-sewn, and DBSS sutures. The Mann–Whitney U test revealed a significant difference between OTSC and hand-sewn sutures (p = 0.0001). There was no significant difference between OTSC and DBSS sutures (p = 0.533), while a significant difference was found between hand-sewn and DBSS sutures (p = 0.0001).

Conclusions

Pure EFTR is feasible if the mechanical counter traction system is used to expand a small operative field and DBSS is used to make full-thickness sutures. The high safety of full-thickness resection and full-thickness suturing allows for clinical applications of this method.

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Acknowledgments

The authors acknowledge Zeon Medical Co., Tokyo, Japan (XEMEX, Japan), Japan NOTES, and the Kagawa NOTES project for supporting this study.

Disclosures

Drs. Hirohito Mori, Hideki Kobara, Shintaro Fujihara, Noriko Nishiyama, Kazi Rafiq, Makoto Oryu, Masao Fujiwara, Yasuyuki Suzuki, and Tsutomu Masaki have no conflicts of interest and no financial arrangement with any company, institution, or third party.

Author information

Correspondence to Hirohito Mori.

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Supplementary material 3 (MPG 11422 kb)

Supplementary material 4 (MPG 21852 kb)

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Mori, H., Kobara, H., Fujihara, S. et al. Feasibility of pure EFTR using an innovative new endoscopic suturing device: the Double-arm-bar Suturing System (with video). Surg Endosc 28, 683–690 (2014) doi:10.1007/s00464-013-3266-z

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Keywords

  • Pure endoscopic full-thickness resection
  • Over-the-scope clip
  • Double-arm-bar Suturing System
  • Air leak test