Evaluation of Safety and Efficacy of a Novel Alginate-Based Esophageal Mucosal Wound Protective Gel

Abstract

Background & Objective:

Endoscopic Submucosal Dissection (ESD) effectively treats early gastric cancer, but postoperative complications limit its clinical use. Therefore, this study examines how esophageal mucosal wound protective gels improve wound healing and reduce post-ESD complications.

Methods:

The gels were characterized for physical properties and stability using rheological behavior, injectability, swelling capacity, and enzymatic degradation resistance. Biocompatibility was assessed via hemolysis testing, cytotoxicity assays, and oral mucosal irritation tests. Furthermore, wound repair potential was evaluated through cell proliferation, migration, and cell cycle analysis in Het-1A cells. Finally, in vivo recovery experiments were conducted to assess post-ESD wound healing efficacy.

Results:

The gels exhibited favorable physical properties, chemical stability, and biocompatibility. Specifically, they maintained stability in the digestive tract, underwent rapid gelation at 37°C, and promoted cell proliferation. Post-ESD evaluation further revealed improved mucosal healing with no significant bleeding events.

Conclusion:

The developed esophageal mucosal wound-protective gels fulfill the requirements for submucosal interventions and show promising potential for ESD wound repair via rapid in situ gelation. This platform could be adapted for various endoscopic procedures and provides new insights for digestive tract tissue engineering applications.

Impact Statement

Endoscopic mucosal dissection (ESD) is recognized as an effective therapeutic modality for early digestive tract cancers; however, the postoperative complications associated with this procedure remain a significant clinical challenge. In this study, we systematically evaluated the application value of a novel esophageal mucosal wound protective gel in facilitating wound repair after ESD. Furthermore, we investigated potential novel application domains of alginate within this context. The results demonstrated that the assessed gel not only optimized the surgical procedure but also significantly enhanced patient outcomes, thus presenting a promising direction for regenerative medicine in the realm of digestive tract tissue engineering and wound repair.