A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial

Abstract

Background Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. Methods This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. Results There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P = 0.02). Conclusions This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.

Self-assembling peptide haemostatic gel reduces incidence of pelvic collection after total mesorectal excision: Prospective cohort study

“…These SAPs form a three-dimensional nanofibre matrix when exposed to ionic fluids [ 8 ]. PuraStat is approved and CE marked for haemostasis during surgery in oozing bleeding in parenchyma of solid organs, vascular anastomoses and small vessels and capillaries in the gastrointestinal tract; it is additionally indicated for reduction of delayed bleeding following colonic ESD - endoscopic submucosal dissection [ [8] , [9] , [10] ]. We have considered the use of SAP only for the haemostatic purpose, and not for other reasons.…”

“…PuraStat® (3-D Matrix Europe SAS, France) is an inert, synthetic, transparent haemostatic hydrogel comprised of self-assembling peptides (SAPs), which spreads easily over uneven surfaces and hard to reach areas [ 8 ]. Previous studies in resectional endoscopy [ [8] , [9] , [10] ], ENT - ear, nose and throat surgery [ 11 ] and cardiothoracic surgery [ [12] , [13] , [14] , [15] ] have revealed a significant reduction in the post-procedural complications with use of this product which reduces the oozing from capillaries and prevents secondary haemorrhage. The potential usage of a transparent SAP in colorectal resections has not been studied and presented so far.…”

Clinical Use of the Self-Assembling Peptide RADA16: A Review of Current and Future Trends in Biomedicine

“…The same United Kingdom group subsequently designed a randomized trial to compare RADA16 (PuraStat) adjunctive use (interventional group) against thermal coagulation-only (control group) for controlling IPB during ESD ( Subramaniam et al, 2020 ). No other treatments (prophylactic coagulation or clipping) were performed in either group.…”

“…The Control group had 269 IPBs in 45 subjects and RADA16 group experienced 232 IPBs in 46 patients ( Subramaniam et al, 2020 ). The RADA16 group demonstrated a 50% reduction in the use of diathermy, with an overall 92.6% hemostatic effectiveness rate.…”

“…An increased healing rate was observed after 1 week, and scarring was more extensive than anticipated between 4 and 8 weeks post-operatively, leading the authors to conclude that RADA16 might improve healing of ESD-induced gastric ulcers. In the randomized control trial that explored RADA16 use during esophageal and colorectal ESD ( Subramaniam et al, 2020 ), resection base healing was a secondary study end point. At 4 weeks post-procedure, 75% of RADA16 ulcers showed either complete wound healing or scarring compared with only 54% of ulcers in the diathermy-only group.…”