PuraStat prevents esophageal stenosis after endoscopic submucosal dissection for esophageal squamous cell carcinoma: multicenter prospective study

Background: PuraStat (self-assembling peptide hemostatic gel) is a novel self-assembling peptide-based hemostatic agent that forms a transparent hydrogel upon contact with blood or bodily fluids. It has been reported to reduce the number of coagulations required with hemostatic forceps during gastrointestinal endoscopic procedures. In addition to its hemostatic effect, recent studies have suggested that PuraStat promotes wound healing. This study aimed to investigate the efficacy of PuraStat in preventing esophageal stenosis following endoscopic treatment of esophageal squamous cell carcinoma. Methods: This study was a single-arm, multicenter, prospective study. Patients with esophageal squamous cell carcinoma who underwent endoscopic submucosal dissection and had a post-resection ulcer involving ≥3/4 of the full circumference of the esophagus received PuraStat application twice: once immediately after the procedure and once at second-look endoscopy 2–4 days later. The primary endpoint was the incidence of esophageal stenosis within 12 weeks after endoscopic submucosal dissection. The secondary endpoints included the number of endoscopic balloon dilation procedures required and the incidence of adverse events and serious adverse events. Results: Twenty patients were enrolled, all of whom received PuraStat application. The incidence of esophageal stenosis within 12 weeks was 20% (4/20). All cases of stenosis resolved with fewer than six endoscopic balloon dilation procedures, and no patients developed refractory esophageal stenosis. Adverse events were observed in four patients; however, all resolved with conservative management. Conclusion: PuraStat application for post-endoscopic submucosal dissection ulcers in patients with esophageal squamous cell carcinoma may be useful for preventing esophageal stenosis.