Initial clinical trial of a novel hemostat, TDM-621, in the endoscopic treatments of the gastric tumors

• Published in: Journal of gastroenterology and hepatology Vol. 29; no. S4; pp. 77 - 79
• Main Authors: Yoshida, Masashi, Goto, Naoki, Kawaguchi, Minoru, Koyama, Hidehiko, Kuroda, Junko, Kitahora, Tetsuji, Iwasaki, Hiroyuki, Suzuki, Shinji, Kataoka, Mikinori, Takashi, Fujii, Kitajima, Masaki
• Format: Journal Article
• Language: English
• Published: Australia Blackwell Publishing Ltd 01.12.2014
• Subjects: Adult; Aged; bleeding; endoscopic mucosal resection; endoscopic submucosal dissection; Feasibility Studies; Female; gastric cancer; Gastric Mucosa - surgery; Gastrointestinal Hemorrhage - drug therapy; Gastroscopy - methods; hemostasis; Hemostatics - therapeutic use; Humans; Male; Middle Aged; Peptides - therapeutic use; Postoperative Hemorrhage - drug therapy; Stomach Neoplasms - surgery; Treatment Outcome; Young Adult; endoscopic mucosal resection; endoscopic submucosal dissection; bleeding; hemostasis; gastric cancer
• ISSN: 0815-9319; 1440-1746; 1440-1746
• DOI: 10.1111/jgh.12798

Background and Aim The feasibility of TDM‐621, the synthetic infectious agent‐free peptides, was tested in hemostasis of the bleeding after endoscopic treatments of the gastric tumors. Methods The patients who underwent endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) were enrolled in the present study. The subject of hemostasis was the oozing after the EMR or ESD. The hemostatic effect, the secondary hemorrhage from one postoperative day to the day before discharge and operability were studied. Results The hemostatic effects were assessed in 12 patients. It was “remarkably effective” in 11 patients and “effective” in 1 patient. The operability was “very easy” in two patients, “easy” in eight patients and “acceptable” in two patients. No secondary hemorrhage was observed in all of 12 patients. No adverse effect considered to be related to TDM‐621 was observed. Conclusion It was shown that hemostasis using TDM‐621 was feasible after endoscopic treatments of the gastric tumors without any technical trouble or adverse event.