Conventional Versus Underwater Endoscopic Mucosal Resection for Superficial Non-Ampullary Duodenal Epithelial Tumors ≤ 20 mm: Study Protocol for a Multicenter Randomized Controlled Trial (D-CURE Trial).

ABSTRACT: Background: Underwater endoscopic mucosal resection (UEMR) is a relatively new treatment method for sporadic non-ampullary duodenal epithelial tumors (SNADETs), and its usefulness has been reported for SNADETs ≤ 20 mm. However, its effectiveness and safety compared with conventional endoscopic mucosal resection (CEMR) remain controversial. This study aims to assess the treatment outcomes and evaluate the beneficial effects and safety of UEMR for SNADETs ≤ 20 mm. Methods: This is an open-label, multicenter collaborative, non-inferiority randomized controlled trial with two parallel groups conducted across 40 institutions in Japan. The study subjects will be patients with SNADETs ≤ 20 mm. A total of 320 patients will be randomized to either the CEMR or UEMR group in a 1:1 alloc

SUBMITTER: Yoshida M 

PROVIDER: S-EPMC12942838 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature