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本論文は 2014 年 3 月 24 日,Digestive Endoscopy にオンラインパブリケーション(http://onlinelibrary.wiley.com/doi/10.1111/den.12268/abstract)された「Evaluation of 0.6% sodium alginate as a submucosal injection material in endoscopic submucosal dissection for early gastric cancer」の第 2出版物(Second Publication)であり,Digestive Endoscopy 誌編集委員会から掲載許可を得ている.また,本論文は和文誌編集委員会からの推薦を経て審査,改訂の後,採用されたものである.
1 77 M M 0-Ⅱc なし 31 4 1 35 well M - - 0 0 なし2 67 F L 0-Ⅰ なし 30 15 1 65 adenoma - - - - - なし3 67 M L 0-Ⅱc なし 48 22 1 240 mod M - - 0 0 なし4 72 M L 0-Ⅱc なし 30 22 1 165 well M - - 0 0 なし5 77 M L 0-Ⅱa+Ⅱc あり 48 21 1 330 mod SM2 - - 0 0 なし6 66 M L 0-Ⅰ なし 40 20 1 130 pap M - - 0 0 なし7 69 M L 0-Ⅱa+Ⅱc なし 30 7 1 75 well M - - 0 0 なし8 65 F L 0-Ⅱc なし 30 21 1 75 mod SM2 - - 0 0 なし9 56 M L 0-Ⅱc なし 33 14 1 120 mod M - - 0 0 なし10 76 M M 0-Ⅱc なし 34 17 1 70 mod M - - 0 0 なし
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1) Department of Gastroenterological and Pediatric Surgery, Oita University. 2) Center for Community Medicine, Oita University Faculty of Medicine. 3) Tenshindo Hetsugi Hospital. 4) Kaigen Pharma CO.,Ltd. 5) Oita University.
Background : We have been studying the potential use of sodium alginate solution in endoscopic submucosal dissection (ESD). Previous sodium alginate solutions were too viscous to handle. This time, we conducted a basic experiment to optimize the physical property of sodium alginate solu-tion and conducted a clinical study to evaluate the safety of the optimized solution.Methods : Sodium alginate solutions of concentrations varying from 0.3% to 0.8% were prepared and evaluated in terms of ease to inject through a catheter and to raise the mucosa, using a 0.4% sodium hyaluronate solution as control. A prospective clinical study was then conducted using a 0.6% sodium alginate solution for ESD in 10 patients with gastric neoplasm.Results : Compared with the 0.4% sodium hyaluronate solution, the 0.6% sodium alginate solution showed no significant difference in ease to inject through a catheter, but it was significantly supe-rior regarding raising of the mucosa. No adverse events occurred in any subjects in the clinical study.Conclusions : The 0.6% sodium alginate solution proved to be safe as a submucosal injectant, suggesting that a larger clinical study to confirm its usefulness is warranted.