臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 07, 2026
Last modified on	Jan. 07, 2026
Trial ID	jRCT1052250183

Scientific Title	A Single-Center Prospective Randomized Controlled Trial Evaluating the Efficacy of Tip-in Underwater Endoscopic Mucosal Resection for Nonampullary Superficial Duodenal Epithelial Tumors Measuring 10-20 mm
Public Title	A Prospective Comparative Study Evaluating the Effectiveness of a Novel Endoscopic Resection Technique (Tip-in UEMR) for Superficial Duodenal Tumors Measuring 10-20 mm

Contact for Scientific Queries	Name	Yoshii Shunsuke
	Affiliation	Osaka International Cancer Institute
	Address	3-1-69 Otemae, Chuo-ku, Osaka, Osaka 541-8567, Japan
	Telephone	+81-6-6945-1181
	E-mail	shunsuke.yoshii@oici.jp
Contact for Public Queries	Name	Matsuyama Kazuki
	Affiliation	Osaka International Cancer Institute
	Address	3-1-69 Otemae, Chuo-ku, Osaka, Osaka 541-8567, Japan
	Telephone	+81-6-6945-1181
	E-mail	matsuyama.kazuki.kyotomed@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 07, 2026
Target sample size		76
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients will be considered eligible if all of the following criteria are met. The lesion has been diagnosed as a superficial nonampullary duodenal epithelial tumor (SNADET) based on endoscopic and/or histological findings. The lesion has an endoscopically assessed maximum diameter of 10-20 mm. The depth of invasion is endoscopically assessed as being confined to the mucosa. The patient is 18 years of age or older at the time of enrollment. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. The most recent laboratory test results obtained within 3 months prior to enrollment meet all of the following criteria. White blood cell count >= 2000/mm3 and <= 12000/mm3. Hemoglobin >= 8.0 g/dL. Platelet count >= 100000/mm3. Total bilirubin <= 2.0 mg/dL. Aspartate aminotransferase (AST) <= 150 U/L and alanine aminotransferase (ALT) <= 150 U/L. Serum creatinine <= 2.0 mg/dL. Written informed consent has been obtained from the patient prior to participation in the study.
	Exclusion Criteria	Patients will be excluded if any of the following criteria are met: Pedunculated lesions. Lesions involving the major duodenal papilla or the minor duodenal papilla. Residual or recurrent lesions. Multiple adenomas associated with familial adenomatous polyposis. Patients judged by the principal investigator or sub-investigators to be inappropriate for participation in the study.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Superficial non-ampullary duodenal epithelial tumor (SNADET)
Intervention(s)		The treatment will be determined by randomization.
Health Condition(s) Keyword		SNADET, UEMR
Intervention(s) Keyword		randomization
Health Condition(s) Code		Duodenal Neoplasms/ D004709
Intervention(s) Code		Random Allocation/ D011985
Primary Outcome(s)		Histological en bloc complete resection rate in the full analysis set (FAS)
Secondary Outcome(s)		Histological en bloc complete resection rate in the per-protocol set (PPS) Endoscopic en bloc resection rate Procedure time Defect closure time Incidence of adverse events Rate of residual or recurrent lesions on follow-up endoscopy

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Osaka International Cancer Institute Clinical Research Review Committee
Address	3-1-69 Otemae, Chuo-ku, Osaka, Osaka 541-8567, Japan, Osaka
Telephone	+81-6-6945-1181
E-Mail	rinri01@opho.jp
Approval Status	Approval
Date of approval	Dec. 16, 2025

Plan to share IPD	No
Plan description	n/a

Countries of Recruitment（Except Japan）	none