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An innovative next-generation endoscopic submucosal injection material with a 2-step injection system (with video) - 18/01/21

Doi : 10.1016/j.gie.2020.06.031 
Ryohei Hirose, MD, PhD 1, 2, , Takaaki Nakaya, PhD 2, Yuji Naito, MD, PhD 1, Takuma Yoshida, MD 1, Risa Bandou 2, Tomo Daidoji, PhD 2, Ken Inoue, MD, PhD 1, Osamu Dohi, MD, PhD 1, Naohisa Yoshida, MD, PhD 1, Yoshito Itoh, MD, PhD 1
1 Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan 
2 Department of Infectious Diseases, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan 

Reprint requests: Ryohei Hirose, Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.Department of Molecular Gastroenterology and HepatologyGraduate School of Medical ScienceKyoto Prefectural University of Medicine465 Kajii-choKawaramachi-HirokojiKamigyo-kuKyoto602-8566Japan

Abstract

Background and Aims

Next-generation submucosal injection materials (SIMs) with higher performance and flexibility than the current SIMs (eg, 0.4% sodium hyaluronate solution [HA]) are expected to improve the outcomes of endoscopic submucosal dissection (ESD) but are difficult to develop. We developed a next-generation SIM by devising a 2-solution-type SIM comprising 2.0% calcium chloride solution (Ca) and 0.4% sodium alginate solution (SA) and evaluated its performance.

Methods

Viscoelasticity, submucosal elevation height, and injection pressure of HA, SA, and the next-generation SIM were measured. Outcomes of ESDs on pseudo-lesions in ex vivo porcine stomach/colon models were compared.

Results

The dramatic increase in SA viscoelasticity with the addition of Ca facilitated the formation of highly viscous submucosal cushions that can be controlled by endoscopists. The submucosal elevation height of the next-generation SIM was significantly higher than that of HA or SA with the same injection pressure. The ESD procedure time using the next-generation SIM was significantly shorter than that using HA or SA (14.2 ± 6.1 vs 29.2 ± 9.1 minutes, P = .0004, or 14.2 ± 6.1 vs 29.1 ± 5.9 minutes, P <.0001). Furthermore, the total injection volume for the next-generation SIM was considerably lower than that for HA or SA (7.0 ± 0.9 vs 17.2 ± 3.4 mL, P <.0001, or 7.0 ± 0.9 vs 16.2 ± 2.9 mL, P <.0001).

Conclusions

We developed an ideal next-generation SIM that achieved high performance and high flexibility in ex vivo models. Our findings warrant further investigations in a patient population.

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Abbreviations : Ca, ESD, HA, IP, SA, SEH, SIM, VAS


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 DISCLOSURE: Dr Hirose received a collaboration research fund from Fuso Pharmaceutical Industries and Kao Corporation. Dr Naito received a scholarship fund from EA Pharma and a collaboration research fund from Taiyo Kagaku and has been paid lecture fees by Mylan EPD, Takeda Pharma, Mochida Pharma EA Pharma, Otsuka Pharma, Nippon Kayaku, and Miyarisan Pharma. Dr Dohi received a research fund from Fujifilm. Dr Itoh received personal fees from Gilead Sciences and AbbVie, and received funding from Takeda Pharmaceutical, AbbVie, Merck Sharp & Dohme, Bayer Yakuhin, Bristol-Myers Squibb, and Novo Nordisk. This study was not funded by these funds. Neither the funding agency nor any outside organization participated in the study design or has any conflict of interest. All other authors disclosed no financial relationships relevant to this publication.


© 2021  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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