THE USE OF A SELF-ASSEMBLING PEPTIDE GEL TO PREVENT ESOPHAGEAL STENOSIS DEVELOPMENT AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION: A U.S. MULTICENTER PROSPECTIVE STUDY

Background: Esophageal stenosis is a potential risk after endoscopic submucosal dissection (ESD), with incidence ranging from 70-90% among those with mucosal defects involving more than three-quarters of the circumference of the esophagus. Application of a self-assembling peptide (SAP) gel after circumferential ESD in a porcine model has been shown to reduce occurrence of stenosis. We aimed to evaluate the use of this SAP gel for stenosis prevention after esophageal ESD in humans.
Methods: Multicenter prospective study of patients who underwent esophageal ESD between March 2022 to September 2023. Patients were included if they underwent esophageal ESD with mucosal defects involving ≥ 50% of the circumference. SAP gel (Purastat, 3D-Matrix, Tokyo, Japan) was applied immediately following ESD. Esophageal stenosis was defined as cases in which an ordinary-sized 9.8 mm endoscope could not pass through the esophagus and/or symptoms of dysphagia with any narrowing of the esophageal lumen on follow-up. Very high-risk cases were defined as those with mucosal defects involving ≥75% of the circumference.
Results: A total of 35 patients (median age 72.5 years; 80% male) underwent ESD with mucosal defects ≥ 50% of the circumference of the esophagus (Table 1). Most lesions (33/35; 94.3%) were in the distal esophagus/gastroesophageal junction. Median lesion and resected specimen size were 30 (interquartile range [IQR]: 21-40) mm and 50 (IQR: 40-55) mm, respectively. Median mucosal defect longitudinal length was 50 (IQR: 40-60) mm. Overall, esophageal stenosis occurred in 7 out of the 35 patients (20%) at repeat endoscopy (median 2 months; IQR: 1-5). Stenosis occurred in 33.3% (6/18) of the very high-risk cases: 4/4 (100%) among those with mucosal defects involving the entire circumference; and 14.3% (2/14) of those involving between <100% and ≥75%. Characteristics of patients with esophageal stenosis and their management are shown in Table 2. All cases were adequately managed endoscopically with resolution of stenosis and/or symptoms. Three patients (8.6%) developed post-procedural bleeding, of which 2 required repeat endoscopy and 1 was managed expectantly.
Conclusions: The novel SAP gel has been suggested to accelerate mucosal healing by promoting re-epithelialization. In this multicenter prospective study, the rate of esophageal stenosis in very high-risk patients was lower than expected based on the literature. Application of the SAP gel immediately after esophageal ESD may reduce the overall risk of stenosis development in patients with mucosal defects involving more than half of the circumference of the esophagus. Future larger comparative studies are needed to corroborate these initial findings.