Endoscopic application of novel, infection‐free, advanced hemostatic material: Its usefulness to upper gastrointestinal oozing

Abstract

Background Self‐assembling peptides (TDMs) comprise synthetic amphipathic peptides that immediately react to changes in pH and/or inorganic salts to transform into a gelatinous state. The first generation of these peptides (TDM‐621) is currently used as a hemostatic agent in Europe. However, TDM‐621 exhibits slow gel‐formation and low retention capabilities on tissue surfaces. The second generation (TDM‐623) was therefore developed to encourage faster gel‐formation and better tissue‐sealing capabilities. Aim The aim of this study was to verify the efficacy of TDM‐623 in terms of its hemostatic effect in endoscopic surgery. Materials and methods Evaluation of the hemostatic effect in endoscopic surgery (animal study) was performed using eight porcine in spine position. Following systemic heparinization, we established a “bleeding model” by endoscopic grasping forceps on the anterior walls of the stomach and duodenum. In the hemostasis method, an endoscope with a distal hood was brought into contact with the bleeding point, and 1 ml TDM‐623 was applied to the wound. After TDM‐623 gelation, the endoscope was removed, and the acute hemostatic effect (after 2 min) was confirmed. Result In the endoscopic bleeding model, 17 of the 23 cases (74%) showed complete hemostatic effects on the anterior wall of the stomach, and 18 of the 20 cases (80%) on the anterior wall of the duodenum, respectively. None of the applied gels were displaced from the anterior walls of the stomach and duodenum. Conclusion The new self‐assembling peptide (TDM‐623) showed high hemostatic effects. TDM‐623 had potential usefulness for upper gastrointestinal endoscopic surgery.

Comparison of PuraStat self-assembling peptide hydrogel versus mineral-based Hemospray for endoscopic hemostasis of upper and lower gastrointestinal lesions in pigs

“…Application of the PuraStat peptide to 5-cm circumferential ESD lesions created in pig esophagi facilitated mucosal epithelial regeneration and reduced the incidence of esophageal stricture (18, 19). More recently, monotherapeutic application of a self-assembling peptide with structure similar to PuraStat was evaluated on endoscopically created GI defects in heparinized pigs (20). Hemostasis was achieved within 2 min in 73% of stomach lesions and 80% of duodenal lesions, with no re-bleeding events occurring during a 5-min observation window.…”

“…The healthy swine model was chosen as the experimental species for this study because the size and anatomy of the gastrointestinal system is clinically relevant for testing human gastrointestinal medical treatments, and its established use for evaluating topical GI hemostats (5,(16)(17)(18)(19)(20)(21)(22)(23). Six adolescent male Yorkshire swine (41.7−51.9 kg) were purchased from Animal Biotech Industries (Danboro, PA) and acclimatized for ≥12 days before undergoing procedures.…”

Case of a novel self‐assembling peptide hemostatic gel as a therapeutic tool for endoscopic ultrasound‐guided tissue acquisition‐related bleeding

“…Bleeding is one of a few adverse events for EUS‐TA 1 . Recently, a novel self‐assembling peptide hemostatic gel was reported to be safe and effective against bleeding 2–5 . We herein describe a case of endoscopic hemostasis for post‐EUS‐TA bleeding using a novel hemostatic gel.…”

Short Peptide Nanofiber Biomaterials Ameliorate Local Hemostatic Capacity of Surgical Materials and Intraoperative Hemostatic Applications in Clinics

“…EAK16, FEK8, and KLD12 peptides to date have been evidenced to form completely transparent hydrogels with highly homogeneous and entangled peptide nanofiber scaffolding matrix. [ 12a,67 ] Some other peptide isoforms or derivatives gradually become high‐end research products, for instance, IEIK13, [ 68 ] TDM‐623, [ 69 ] that consist of 14 amino acid residues. In these dSAP scaffolds, due to regular tandem‐repeated polypeptide sequence and ionic self‐complementary molecular arrangement, short dSAP sequences can afford functional motifs to modify the peptide nanofiber backbones and act as provisional cell or protein‐entrapped scaffolds.…”

“…Due to the ionic self‐complementary chemical chain forming well‐defined hierarchical nanostructures, RADA16 nano‐hemostat has high shear‐thinning fluidity and thixotropic viscous properties via intermolecular self‐assembly, which are well‐suited for endoscopic application via the narrow delivery catheter and allows the hemostatic solution to flow easily into the bleeding tissue surface. [ 13 ] Moreover, other dSAP biomaterials have also exhibited unprecedented advantages for hemostatic applications, such as specific bleeding surface adhesion, [ 111 ] instant hemostatic efficacy, [ 69 ] and non‐immunogenic biosafety, [ 22a ] except for Q11 peptide supramolecular platform of intracorporal vaccination in the self‐adjuvanticity of dSAP nanofibers [ 112 ] ; that is other valuable research field beyond the scope of this review.…”