A fully synthetic and self-assembling peptide solution: a novel submucosal injection material in endoscopic submucosal dissection

Aims Successful endoscopic submucosal dissection (ESD) requires an injection solution to create a submucosal cushion, ensuring safe endoscopic resection. Recently, a fully synthetic, self-assembling peptide solution known as “PuraLift” (3-D Matrix, Tokyo, Japan) has been developed as a submucosal injection material. This non-biological preparation self-assembles into a nanofiber gel when exposed to a neutral pH. It contains the same active ingredients as the peptide hemostatic agent “PuraStat” (3-D Matrix). This study aimed to investigate the safety and feasibility of using PuraLift in ESD for early-stage gastrointestinal neoplasms.

Methods This prospective, single-arm, single-center feasibility study included eleven patients with early-stage gastrointestinal neoplasms of the stomach (n=5) or colorectum (n=6) who underwent ESD. Exclusion criteria included residual or local recurrent lesions, ulceration of the target lesions, multiple lesions, a history of hypersensitivity to peptide or protein preparations, bleeding tendency, and pregnancy. After submucosal injection of PuraLift, mucosal incision and submucosal dissection were initiated from the anal side of the lesion using a DualKnife J (Olympus Co., Tokyo, Japan) and an electrosurgical generator (VIO3, ERBE, Tübingen, Germany, dry cut mode 2.0, swift coagulation mode 3.5). All patients underwent outpatient follow-up at 4 weeks to monitor adverse events. None of the observed adverse events were attributed to the study treatment. Questionnaires assessing ease of use for operators and assistants were conducted, comparing PuraLift with normal saline.

Results The median specimen size was 40 mm (range: 20–70 mm). En bloc and R0 resections were achieved in all patients without intraprocedural adverse events. The median operation time was 52 minutes (range: 22–130 minutes), and the median volume of PuraLift used was 32 mL (range: 22–130 mL). No postoperative bleeding or delayed perforation occurred in any patient. Injection ease with PuraLift was rated as comparable across all cases, mucosal incision was rated as easy in 2 cases and comparable in 9, submucosal dissection was rated as comparable in all cases, and mucosal lifting was maintained longer in 9 cases, comparable in 2.

Conclusions The novel injectable material, PuraLift, shows potential for safe and feasible use in gastric and colorectal ESDs. Further studies with a larger sample size, multicenter comparison, and long-term follow-up are required to confirm its efficacy and safety.