EndoClot®SIS Polysaccharide Injection as a Submucosal Fluid Cushion for Endoscopic Mucosal Therapies: Results of Ex Vivo and In Vivo Studies
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There are many studies on submucosal injection materials, but their clinical use is restricted for various reasons. The objective of this study was to compare the feasibility and safety of injected EndoClot®SIS polysaccharide as a submucosal injection material (SFC) in ESD in the pig stomach to that of injected sigMAVisc™ or Eleview™.
Four pig stomachs were used for the ex vivo study. Eighteen pigs were used for the in vivo study. In the ex vivo study, four injections were made in the gastric submucosa to induce submucosal uplift and extend its duration. Tissue change was observed. The in vivo study was performed in 2 steps. First, 3 injections were made in the esophageal mucosa to induce submucosal uplift and extend its duration. Histological change was observed. Second, ESD was performed in the stomach by injecting EndoClot®SIS polysaccharide, sigMAVisc™, or Eleview™ (each, n = 6) as an SFC. The effects of these agents on wound healing were examined. We evaluated the efficacy and safety of endoscopic surgery after EndoClot®SIS polysaccharide injection.
EndoClot®SIS polysaccharide produced a longer-lasting elevation with clearer margins than was achieved by sigMAVisc™, Eleview™, or 0.9% NaCl and thereby enabled precise ESD without complications, such as bleeding and perforation. No obvious histopathological damage was observed at the injection site on endoscopy and histology.
Submucosally injected EndoClot®SIS polysaccharide increased the effective separation of the mucosa and submucosa and reduced surgical complications. Hence, EndoClot®SIS polysaccharide injection is a safe and effective submucosal injection material.
KeywordsSubmucosal injection Endoscopic submucosal dissection EUS Experiments on animals
The authors are grateful to Suzhou AnDeJia Biotechnology Co., Ltd. for providing injection materials.
Ming-Sen Dai and Ke-Wei Hu designed the study; Guo-Jian Yin, Wei Wu, Duan-Min Hu performed the experiments; and Ming-Sen Dai analyzed the data and, and wrote the manuscript.
This study was supported by grants from the Jiangsu Province Young Medical Talents Program (No. 2016-2020) and the Health Bureau of Suzhou (Nos. SYZ201632 and SS201641).
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All applicable international, national, and/or institutional guidelines for the care and use of animals were followed.
- 5.Uraoka T, Saito Y, Yamamoto K, et al. Submucosal injection solution for gastrointestinal tract endoscopic mucosal resection and endoscopic submucosal dissection. Drug Des Devel Ther. 2009;2:131–138.Google Scholar
- 11.Makuuchi H, Mitomi T, Machimura T, et al. Endoscopic mucosal resection for early esophageal cancer by EMR-tube method. Stomach Intest. 1988;28:153–159.Google Scholar
- 24.Tada M, Shimada M, Murakami F. Development of strip-off biopsy. Gastroenterol Endosc. 1984;26:833–839.Google Scholar
- 32.Liu W, Wang M, Zhao L, et al. Thermo-sensitive isopentane aerification for mucosal lift during endoscopic resection in animal models (with video). Gastrointest Endosc. 2017;86:1168.e3–1175.e3.Google Scholar