{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T17:31:52Z","timestamp":1781026312820,"version":"3.54.1"},"reference-count":36,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T00:00:00Z","timestamp":1771804800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["MPs"],"abstract":"<jats:p>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 \u2264 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 \u2264 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 \u2264 20 mm. A total of 320 patients will be randomized to either the CEMR or UEMR group in a 1:1 allocation ratio. The primary endpoint is the 1-year recurrence-free survival rate, defined as the number of cases with no recurrence of SNADET or death from any cause within one year of EMR. The secondary endpoints include the en bloc resection rate, histological complete resection rate, adverse events, technical success rate, total procedure time, resection time, mucosal closure time, complete mucosal closure rate, complete mucosal closure rate with standard clips, 1-year duodenum preservation survival rate, and device cost. Discussion: This multicenter, open-label, randomized controlled trial (RCT) with 320 subjects aims to determine whether the 1-year recurrence-free survival rate of underwater endoscopic resection is not inferior to that of conventional endoscopic mucosal resection for SNADETs \u2264 20 mm. If the efficacy and safety of UEMR are proven in this RCT, it is expected to be recognized as the standard treatment for SNADETs \u2264 20 mm. Owing to the absence of submucosal injection, UEMR is a simpler and more cost-effective technique compared to CEMR and is anticipated to become the primary method of EMR.<\/jats:p>","DOI":"10.3390\/mps9010030","type":"journal-article","created":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T10:00:52Z","timestamp":1771840852000},"page":"30","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Conventional Versus Underwater Endoscopic Mucosal Resection for Superficial Non-Ampullary Duodenal Epithelial Tumors \u2264 20 mm: Study Protocol for a Multicenter Randomized Controlled Trial (D-CURE Trial)"],"prefix":"10.3390","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7272-0187","authenticated-orcid":false,"given":"Masao","family":"Yoshida","sequence":"first","affiliation":[{"name":"Division of Endoscopy, Shizuoka Cancer Center, Shizuoka 411-8777, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waku","family":"Hatta","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Tohoku University Graduate School of Medicine, Miyagi 980-8574, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Faculty of Data Science, Kyoto Women\u2019s University, Kyoto 605-8501, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Nakaya","sequence":"additional","affiliation":[{"name":"Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, Miyagi 980-0872, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoki","family":"Shichijo","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka 541-8567, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuyuki","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Kyoto Katsura Hospital, Kyoto 615-8256, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiromitsu","family":"Kanzaki","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Tsuyama Chuo Hospital, Okayama 708-0841, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kingo","family":"Hirasawa","sequence":"additional","affiliation":[{"name":"Division of Endoscopy, Yokohama City University Medical Center, Kanagawa 232-0024, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ichiro","family":"Oda","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Kawasaki Rinko General Hospital, Kanagawa 210-0804, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Hirose","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Aichi 466-8550, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motohiko","family":"Kato","sequence":"additional","affiliation":[{"name":"Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo 160-8582, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohei","family":"Takizawa","sequence":"additional","affiliation":[{"name":"Department of Endoscopy, Kanagawa Cancer Center, Kanagawa 241-8515, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Toya","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University, Iwate 020-8505, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9815-1557","authenticated-orcid":false,"given":"Takuto","family":"Hikichi","sequence":"additional","affiliation":[{"name":"Department of Endoscopy, Fukushima Medical University Hospital, Fukushima 960-1295, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Sawai","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Takatsuki General Hospital, Osaka 569-1192, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naohiro","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa 920-8530, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0498-0144","authenticated-orcid":false,"given":"Osamu","family":"Dohi","sequence":"additional","affiliation":[{"name":"Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7184-7282","authenticated-orcid":false,"given":"Atsushi","family":"Masamune","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Tohoku University Graduate School of Medicine, Miyagi 980-8574, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2736-6921","authenticated-orcid":false,"given":"Seiichiro","family":"Abe","sequence":"additional","affiliation":[{"name":"Endoscopy Division, National Cancer Center Hospital, Tokyo 104-0045, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomonori","family":"Yano","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba 277-8577, 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