A NOVEL SELF-ASSEMBLING PEPTIDE HYDROGEL FOR WOUND HEALING: INITIAL RESULTS FOR ENDOSCOPIC TREATMENT OF POST-SURGICAL LEAKS

Introduction:
A novel, self-assembling peptide hydrogel (PuraStat, 3D Matrix, Tokyo, Japan) has recently been FDA-approved with dual indications for hemostasis and wound healing. Initial endoscopic clinical reports of this self-assembling peptide hydrogel (SAPH) have focused on hemostasis, including mild to moderate bleeding associated with conditions like gastric antral vascular ectasia (GAVE), radiation proctitis, as well as post-ESD or EMR wound healing. However, its potential for endoscopic treatment of post-surgical leaks remains relatively unexplored. Our study aims to fill this gap presenting a case series of SAPH specifically in the context of wound healing for post-bariatric surgery leaks.

Case Description/Methods:

Patient 1: 39-year-old male POD5 from RYGB reversal to LSG/duodenal switch presented with half circumferential dehiscence of the duodenal-ileal (DI) anastomosis. The DI leak was endoscopically treated with 2 transmural double pigtail plastic stents (DPPS). By POD50, the DI leak had near-resolved, and both DPPS and the percutaneous drain had been removed. However, there remained a small fistulous tract that was injected with 3 mL of SAPH. By POD89, the fistula tract was fully healed.

Patient 2: 48-year-old female POD31 from LSG presented with a large 4cm proximal staple line dehiscence. Initial treatment was endoscopic vacuum therapy, but it was discontinued after 1 week due to patient intolerance. A covered esophageal metal stent was placed but similarly removed after 1 week due to patient intolerance. These therapies led to 50% cavity reduction. Septotomy was not possible. The cavity was further treated with double pigtail plastic stents and SAPH injection but ultimately persisted, necessitating revisional surgery with fistula-jejunostomy.

Patient 3: 28-year-old male POD10 from LSG presented with a moderate proximal staple line leak accompanied by the development of a proximal-lateral sleeve fistula tract. Extensive lavage was performed in fistula cavity. 3mL SAPH was injected into the area of fistula without concurrent stent placement. By POD143, the fistula tract had healed.

Patient 4: 39-year-old female with LSG, complicated by small, chronic (>2 years) gastric sleeve leak and two fistula tracts (2mm and 6mm), leading to a supradiaphragmatic collection. 9mL SAPH was injected in a 3:1 ratio with contrast through both fistula cavities. One of the two fistulous tracts healed.

Discussion:
Self-Assembling Peptide Hydrogel (SAPH), which has already shown promise for hemostasis, is potentially also an adjunctive wound-healing agent for treatment of post-surgical leaks. It is relatively easy to inject through a catheter and combines well with conventional endoscopic treatments. Our small case series suggests that SAPH may be most helpful for small and/or early gastrointestinal leaks and fistulae. Larger studies are required.