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The usefulness of a double-balloon endolumenal interventional platform for colorectal endoscopic submucosal dissection by non-expert endoscopists in a porcine model (with video)

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Abstract

Background

Endoscopic submucosal dissection (ESD) is an optimal treatment for colorectal tumors; however, it is technically difficult, especially for non-experts. Therefore, a device that helps non-experts perform colorectal ESD would be beneficial. A double-balloon endolumenal interventional platform (DEIP) was recently developed to assist colorectal ESD through endoscope stabilization and traction. This study assessed the usefulness of colorectal ESD using the DEIP (DEIP-ESD) by endoscopists, including non-experts, in a living porcine model.

Methods

Two pigs were used to perform eight DEIP-ESD and eight conventional cap-assisted ESD (C-ESD) procedures. Three experts and five non-experts each resected one lesion using DEIP-ESD and one using C-ESD. We evaluated the treatment outcomes and performed stratified analyses between the experts and non-experts.

Results

Dissection speed was significantly faster in DEIP-ESD than in C-ESD (13.3 mm2/min vs 28.5 mm2/min, P = 0.002). However, the total procedure time did not differ significantly between DEIP-ESD and C-ESD. In the stratified analyses, the dissection speed of non-experts was significantly faster in DEIP-ESD than in C-ESD (10.9 mm2/min vs 25.1 mm2/min, P = 0.016), while that of experts increased in DEIP-ESD but to a lesser extent (19.1 mm2/min vs 28.8 mm2/min, P = 0.1). The total procedure time did not differ between DEIP-ESD and C-ESD for both experts and non-experts. The self-completion rate of non-experts also increased in DEIP-ESD. Moreover, the number of muscularis propria injuries induced by non-experts was fewer in DEIP-ESD than in C-ESD.

Conclusions

DEIP could facilitate colorectal ESD by improving dissection efficiency without increasing adverse events, especially when performed by non-experts.

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Authors and Affiliations

  1. Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

    Hiroki Yamashita, Hiroaki Ikematsu, Tatsuro Murano, Naoki Aoyama, Yuki Kano, Tomohiro Mitsui, Hironori Sunakawa, Kensuke Shinmura, Kenji Takashima, Keiichiro Nakajo, Tomohiro Kadota, Yusuke Yoda & Tomonori Yano

  2. Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, Japan

    Hiroaki Ikematsu

  3. NEXT Medical Device Innovation Center, National Cancer Center Hospital East, Kashiwa, Japan

    Kenji Takashima, Yusuke Yoda & Tomonori Yano

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  1. Hiroki Yamashita
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Contributions

Conception and design: HY, HI, TM, and KS; analysis and interpretation of the data: HY, HI, TM, and KS; drafting of the article: HY, HI, and TM; critical revision of the article for important intellectual content: HI and TM; final approval of the article: all authors.

Corresponding author

Correspondence to Hiroaki Ikematsu.

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Disclosures

Hiroki Yamashita, Hiroaki Ikematsu, Tatsuro Murano, Naoki Aoyama, Yuki Kano, Tomohiro Mitsui, Hironori Sunakawa, Kensuke Shinmura, Kenji Takashima, Keiichiro Nakajo, Tomohiro Kadota, Yusuke Yoda, and Tomonori Yano have no conflicts of interest or financial ties to disclose.

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Supplementary Information

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Supplementary file1 (DOCX 18 KB)

Supplementary file2 (MOV 60373 KB) Video 1 Using the DEIP. After inserting an endoscope with the DEIP into the operation area, the fore-balloon is inflated on the oral side of the lesion, and the endoscope tip is moved backward using the aft-balloon. The aft-balloon is inflated on the anal side of the lesion. After injecting sodium hyaluronate into the submucosal layer, a complete circumferential incision is made, and the anal side of the lesion is trimmed. For obtaining countertraction, the string loop is moved closer by pulling the fore-balloon backward and fastening it to the anal side of the lesion by clip**; thereafter, the fore-balloon is extended outwardly. A desired degree of countertraction is obtained during submucosal dissection by moving the fore-balloon. DEIP, double-balloon endolumenal interventional platform.

Supplementary file3 (MOV 85096 KB) Video 2 Representative procedures of C-ESD and DEIP-ESD performed by an expert and a non-expert. In C-ESD, a non-expert experiences difficulty performing retraction, while an expert can perform retraction using the attachment hood. While the expert takes 16 min to complete the procedure, the non-expert takes 48 min. In DEIP-ESD, the non-expert can perform good retraction and dissect the submucosa safely and fast as an expert can. While the expert takes 16.2 min to complete the procedure, the non-expert takes 24.3 min. C-ESD, conventional cap-assisted endoscopic submucosal dissection; DEIP-ESD, endoscopic submucosal dissection using the double-balloon endolumenal interventional platform.

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Yamashita, H., Ikematsu, H., Murano, T. et al. The usefulness of a double-balloon endolumenal interventional platform for colorectal endoscopic submucosal dissection by non-expert endoscopists in a porcine model (with video). Surg Endosc 36, 7818–7826 (2022). https://doi.org/10.1007/s00464-022-09338-z

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