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

Abstract

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.

S2k-Leitlinie Gastrointestinale Blutung

“…diffuse Blutungssituation kann Anlass zur Anwendung von Hämostasesprays sein. Diesbezüglich liegen erste Fallberichte vor [220,246,247].…”

Updated evidence on endoscopic resection of early gastric cancer from Japan

“…As new attempts to prevent post-ESD ulcer bleeding, TDM-621 (a synthetic infectious-agent-free peptide) and a shielding method that used polyglycolic acid sheets and fibrin glue were tested in clinical trials [15,16]. The former, applied through an endoscopic catheter, was used for oozing hemorrhage during ESD, showing promising results in 12 patients [15]. The latter was used to cover the mucosal defect immediately after ESD for prevention of post-ESD ulcer bleeding.…”

Simplified prophylaxis of mucosal resection site defects

“…Biologic materials produced from animal and human sources carry some concern regarding risk of infection with viruses and prions as well as allergic reactions. Yoshida et al 11 initially studied Pura Matrix (3-D Matrix, Ltd, Tokyo, Japan), a synthetic infectious agent-free hydrogel peptide product for hemostasis, promptly after ESD. This hydrogel formulation is also expected to promote ulcer healing by creating a scaffold-like effect for tissue regeneration.…”