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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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Abstract

Background

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™.

Methods

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.

Results

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.

Conclusion

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.

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Acknowledgments

The authors are grateful to Suzhou AnDeJia Biotechnology Co., Ltd. for providing injection materials.

Funding

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).

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Authors and Affiliations

  1. Department of Gastroenterology, The Second Affiliated Hospital of Soochow University, Suzhou, 215000, Jiangsu, China

    Ming-Sen Dai, Ke-Wei Hu, Wei Wu, Guo-Jian Yin & Duan-Min Hu

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  1. Ming-Sen Dai
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  2. Ke-Wei Hu
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  3. Wei Wu
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  4. Guo-Jian Yin
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Contributions

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.

Corresponding author

Correspondence to Duan-Min Hu.

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All applicable international, national, and/or institutional guidelines for the care and use of animals were followed.

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Dai, MS., Hu, KW., Wu, W. et al. EndoClot®SIS Polysaccharide Injection as a Submucosal Fluid Cushion for Endoscopic Mucosal Therapies: Results of Ex Vivo and In Vivo Studies. Dig Dis Sci 64, 2955–2964 (2019). https://doi.org/10.1007/s10620-019-05686-4

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  • DOI: https://doi.org/10.1007/s10620-019-05686-4

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