Efficacy and safety of MC-003 solution for endoscopic mucosal or submucosal resection: a prospective, multicenter, randomized, triple-blinded, parallel-group, phase III study

Abstract

Background and AimsThe safety and efficacy of solutions for submucosal injection are critical for endoscopic resection of gastric adenomas or early gastric cancers. Although several injectable solutions have been introduced for endoscopic resection, they have some limitations. We aimed to compare the efficacy of the new sodium alginate-based solution MC-003 with that of normal saline (NS, 0.9% sodium chloride). MethodsIn this randomized triple-blind study, 70 patients were initially enrolled for endoscopic mucosal resection or endoscopic submucosal dissection (ESD). The main outcomes included the need for additional injections, completion of en bloc resection, and occurrence of adverse events. ResultsEach group finally comprised 34 patients. Complete en bloc resections were achieved in all patients (P = 1.000). The MC-003 group had more peri-neoplasm tissue fibrosis (P = 0.056) and needed fewer additional injections for lesions larger than 15 mm (P = 0.037), located in the distal part (P = 0.007) and during ESD procedures (P = 0.001), whereas the adverse event rate was comparable in both groups. ConclusionsMC-003 outperformed NS in reducing the need for additional injections during en bloc resection, particularly in larger lesions located in the distal part (where most lesions were found) during ESD procedures, without increasing the incidence of serious adverse events. MC-003 is a promising submucosal injectable solution in real-world clinical settings.