Application of a novel self-assembling peptide to prevent hemorrhage after EMR, a feasibility and safety study

Abstract

Background A novel self-assembling peptide (SAP) can be applied to the post-endoscopic mucosal resection (EMR) defect to treat oozing bleedings. It has been suggested to stimulate early healing of damaged vessels. We hypothesized that SAP application could prevent delayed bleeding (DB) after EMR and performed a prospective cohort study to determine feasibility and safety. Methods A total of 48 consecutive patients who underwent EMR between June 2018 and August 2019 for large lesions in the esophagus, duodenum (> 1 cm) or colorectum (> 2 cm) were treated with adjuvant SAP application. Duration and ease of SAP application were measured, as well as DB outcome. Results The EMR defects of 48 patients were treated with SAP; 17 in the esophagus, 13 in the duodenum and 18 in the colorectum. SAP was easy to apply on the EMR defect with a median duration of 2.0 min. A dose of 3 cc was generally enough to cover a defect between 10 and 50 mm. An exploratory analysis of the prophylactic ability of SAP showed that 15.9% of patients (7/44) treated with SAP still had a DB, mostly in the duodenum (4/11). No adverse events related to gel exposure were reported. Conclusions SAP application after EMR was found to be feasible and safe, and did not delay the procedure; however, DB was still relatively common. Future comparative studies are needed to evaluate whether SAP is able to reduce DB after EMR, particularly for lesions with an increased bleeding risk, such as in the duodenum.

The feasibility of a novel injectable hydrogel for protecting artificial gastrointestinal ulcers after endoscopic resection: an animal pilot study

“…Previous reports have described clinical experiences using PuraStat® (3-D Matrix Europe, Caluire et Cuire, France), a novel hydrogel composed of a synthetic hemostatic material and administered in a prefilled syringe. Soons et al showed in a single-arm study that prophylactic PuraStat application after endoscopic mucosal resection is safe and can be performed within a few minutes; however, the postoperative bleeding rate was not different from that reported with existing methods 20 . In a randomized controlled trial, Subramaniam et al showed that PuraStat is an effective hemostat that can reduce the need for heat therapy to treat bleeding during ESD.…”

“…This may be because the hydrogel flows off the bottom of the ulcer before robust gelation. It has also been reported that the position of the ulcer can affect appropriate gelation 20 . These factors could be relevant because the previously reported hydrogels were composed of a single agent, which makes controlling their physical properties difficult.…”

PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study

“…A very low delayed bleeding rate was found (3%) and the bleeding activity was stopped within 70 s [ 9 ]. The application of PuraStat after EMR is feasible and safe which could be shown in 48 patients [ 20 ]. The most recent RCT of 101 patients comparing PuraStat to cautery reported a haemostatic efficacy rate of 92.6% for intra procedural oozing bleeds encountered during oesophageal or colonic ESD [ 10 ].…”

Preventing Postendoscopic Mucosal Resection Bleeding of Large Nonpedunculated Colorectal Lesions

“…RADA16, the only commercial agent in use, is a transparent, synthetic, self-assembling peptide hemostatic gel that works by forming a hydrogel matrix scaffold on the tissue surface. The rate of delayed bleeding after RADA16 ranged from 0% to 11% in 3 studies (61–63).…”