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

Ah Young Lee; Jae Young Jang; Jun-Young Seo; Seong Hwan Kim; Ji Min Choi; Joo Young Cho

doi:10.1016/j.gie.2024.01.002

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

Gastrointest Endosc. 2024 Jan 4:S0016-5107(24)00005-1. doi: 10.1016/j.gie.2024.01.002. Online ahead of print.

Authors

Ah Young Lee¹, Jae Young Jang², Jun-Young Seo³, Seong Hwan Kim¹, Ji Min Choi¹, Joo Young Cho⁴

Affiliations

¹ Division of Gastroenterology, Department of Internal Medicine, Cha Gangnam Medical Center, College of Medicine, Cha University, Seoul, Republic of Korea.
² Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Republic of Korea.
³ Division of Gastroenterology, Department of Internal Medicine, Bundang Jesaeng General Hospital, Gyeonggi-do, Republic of Korea.
⁴ Division of Gastroenterology, Department of Internal Medicine, Cha Gangnam Medical Center, College of Medicine, Cha University, Seoul, Republic of Korea. Electronic address: cjy6695@naver.com.

PMID: 38184114
DOI: 10.1016/j.gie.2024.01.002

Abstract

Background and aims: The 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).

Methods: In this randomized, triple-blind study, 70 patients were initially enrolled for EMR or endoscopic submucosal dissection (ESD). The main outcomes included the need for additional injections, completion of en bloc resection, and occurrence of adverse events.

Results: Each group ultimately included 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 = .056) and needed fewer additional injections for lesions >15 mm (P = .037), located in the distal portion of the stomach (P = .007) and during ESD procedures (P = .001). The adverse event rate was comparable in both groups.

Conclusions: MC-003 outperformed NS in reducing the need for additional injections during en bloc resection, particularly in larger lesions located in the distal portion of the stomach (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.