Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study

Endoscopic submucosal dissection (ESD) requires an injection solution to create a submucosal cushion for safe endoscopic resection. This study evaluated the safety and feasibility of a new injection solution (PuraLift) in ESD for early-stage gastrointestinal tumors. This prospective, single-arm, single-center pilot study included eleven patients with gastrointestinal neoplasms of the stomach (n=5) or colorectum (n=6) who underwent ESD. All patients underwent outpatient follow-up at week 4 to confirm the presence or absence of adverse events. All underwent protocol treatment and post-treatment follow-up. None of the adverse events were judged to have a cause-and-effect relationship with the study. Questionnaires to the operators who performed the protocol treatment and assistants who performed submucosal injections were evaluated in comparison to saline, and maintenance of mucosal lifting was long, comparable, and short (9/2/0). En bloc and R0 resections were achieved in all patients without intraprocedural adverse events. The median size of the specimens was 40 (range, 20–70) mm. The median excision time was 52 (range, 22–130) min. The median volume of PuraLift was 32 (range, 22–130) mL. No postoperative bleeding or delayed perforation was observed in any patient. The novel injectable material, PuraLift, can potentially ensure safe and feasible in ESD.

Publication History

Received: 23 July 2024

Accepted after revision: 19 November 2024

Accepted Manuscript online:
25 November 2024