Safety and Efficacy of Self-Assembling Peptide Gel in Prevention of Gastrointestinal Bleeding After Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection: A Single Center Experience

Introduction: Delayed bleeding can occur after endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) in up to 15.6% of cases. Current hemostatic methods to minimize delayed bleeding risk have limitations. Epinephrine injection effect is transient. Excessive electrocoagulation may cause thermal damage or perforation. The location and the size of lesions may not permit use of endoclips or endoscopic suturing after endoscopic resection. Recently, a self-assembling peptide (SAP; Purastat) gel was developed as a hemostatic agent, which is applied as transparent, viscous gel via an endoscopic catheter (Figure 1). This study aims to evaluate the efficacy and safety of the peptide gel for prevention of delayed bleeding after large endoscopic resections. Methods: A retrospective observational study was conducted at a tertiary medical center. Patient characteristics and size, location, and pathology of resected gastrointestinal lesions were extracted from the medical record. Primary outcomes were technical success (defined as successful application of the peptide gel), clinical success (absence of bleeding post procedure up to 30 days), and adverse events. Results: 22 patients were included with follow up of 30 days. There were 16 ESD and 6 EMR cases. Baseline clinical and technical data are reported in Table 1. Nine patients (36%) were ASA III and 4 patients (16%) were on anticoagulation. Mean size of the lesion defect was 44.66±21.46 mm. The largest defect size was 100 mm from a circumferential ESD of an esophageal squamous cell carcinoma. Mean volume of the peptide gel used was 5.43±1.73 ml. Technical success rate was 100% (22/22). Clinical success rate at 30 days was 95.5% (21/22). One patient (4.5%) had bleeding 7 days after circumferential ESD of a 50 mm lower esophageal adenocarcinoma. The patient required transfusion of 1 unit of packed red blood cells, a repeat endoscopy with hemostasis using electrocoagulation, and was discharged 1 day after admission. There were no treatment-related adverse events including mucosal injury, perforation, pain, allergic reaction, or thromboembolic events. No deaths were attributed to the procedure. Conclusion: Delayed bleeding can occur in up to 15.6% of all EMR or ESD cases. In very large defects, the risk is proportionally higher. The application of the self-assembling peptide gel is safe and is promising for reducing delayed bleeding risk after large endoscopic resection. Further large studies are necessary to validate these findings.Figure 1.: Demonstration of the application of the self-assembling peptide gel (PuraStat ®; 3D Matrix Ltd, France). In the top photo, the peptide gel is applied to a gastric ESD defect along the incisura. In the bottom photo, the peptide gel is applied to a 10 cm circumferential esophageal ESD defect site. The transparent gel is easy to apply with a supplied catheter and does not obscure the view. Table 1. - Patient Characteristics, Procedure Characteristics and Technical Outcomes Patient Characteristics Age (years, mean ± SD) 66.16 ± 14.75 Gender (male, n, %) 12/22 (55%) Charlson Comorbidity Index (score, mean ± SD) 2.92 ± 1.82 Anticoagulation use, n (%) 4/22 (18%) ASA Class, n (%) I 1/22 (4.5%) II 14/22 (64%) III 9/22 (41%) IV 1/22 (4.5%) Location of the Lesion Defect, n (%) Esophagus 6/22 (27%) Stomach 4/22 (18%) Antrum 3/4 Incisura 1/4 Duodenum 4/22 (18%) Ampulla 1/22(4.5%) D1 1/4 D3 2/4 Colon 8/22 (36%) Cecum 1/8 Ascending colon 2/8 Rectum 5/8 Pathology Esophagus (n=6) Papilloma 1 Esophageal Squamous Cell Carcinoma 3 Barrett’s Esophagus with Low Grade Dysplasia 1 Esophageal Adenocarcinoma 1 Stomach (n=4) Intestinal Metaplasia with Low Grade Dysplasia 2 Intestinal Metaplasia with High Grade Dysplasia 2 Duodenum (n=4) Ampullary adenoma 1 Tubular adenoma with high grade dysplasia 1 Tubulovillous adenoma 1 Tubulovillous adenoma with high grade dysplasia 1 Colon (n=8) Tubular adenoma 3 Tubular adenoma with high grade dysplasia 1 Tubulovillous adenoma 2 Tubulovillous adenoma with high grade dysplasia 1 Intramucosal adenocarcinoma 1 Procedure Details Endoscopic Submucosal Dissection, n (%) 16/22 (73%) Endoscopic Mucosal Resection, n (%) 6/22 (27%) Size of Post Procedure Defect or GI Bleeding Size (mm), mean ± SD 42.08 ± 22.50 Volume of Self-Assembling Peptide Gel (ml), mean ± SD 5.36 ± 1.73 Technical Success Successful Application of Self-Assembling Peptide Gel without Catheter Clogging, Kinking, or Interference with Visibility, n (%) 22/22 (100%) Clinical Success Absence of Bleeding Intra and Post Procedure Up to 30 Days Post Procedure, n (%) 21/22 (95%) Adverse Events Bleeding Requiring Transfusion and Repeat Endoscopy Post Procedure, n (%) 1/22 (4.5%) Treatment-related adverse events including mucosal injury, perforation, pain, allergic reaction or hypersensitivity, thromboembolic events, or hemodynamic instability 0/22 (0%) Death 0/22 (0%)