UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm): a multicenter observational study
Acronym	D-UEMR Study
Scientific Title	Efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm): a multicenter observational study
Scientific Title:Acronym	D-UEMR Study
Region	Japan

Condition
Condition	duodenal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Complete resection rate(Recurrence rate 12 month after UEMR)
Key secondary outcomes	Resected lesion and specimen size En bloc resection rate R0 resection rate Procedure time Total procedure time Total amount of infusion water Adverse events rate

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Nonampullary duodenal tumors less than 20mm in size endoscopically (adenoma or intramucosal cancer) Apart from papillae Within 2 lesions in 1 patient
Key exclusion criteria	Suspect of submucosal invasive cancer Patients with FAP or Lynch syndrome Patients with less than 1 year prognosis Patients who have been judged as in appropriate for this study
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Okada
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	+81-86-235-7219
Email	hiro@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Yamasaki
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	+81-86-235-7219
Homepage URL
Email	yasshifive@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Hospital
Address	2-5-1 Shikata-cyo Okayama
Tel	+81-86-235-7219
Email	yasshifive@yahoo.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	岩国医療センター（山口県） 大阪国際がんセンター（大阪府） 岡山医療センター（岡山県） 岡山大学病院（岡山県） 岡山済生会総合病院（岡山県） 北野病院（大阪府） 京都第二赤十字病院（京都府） 京都府立医科大学附属病院（京都府） 津山中央病院（岡山県） 奈良県西和医療センター（奈良県） 日本赤十字社　和歌山医療センター（和歌山県） 姫路赤十字病院（兵庫県） 広島市民病院（広島県） 福山医療センター（広島県） 三豊総合病院（香川県） 和歌山県立医科大学附属病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 18 Day

Related information
URL releasing protocol	none
Publication of results	Published

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	155
Results	Primary endpoint non-recurrence rate 97.2%(95%CI 92.8-99.1)
Results date posted	2021 Year 12 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	20mm duodenal adenomas
Participant flow	Enrollment before UEMR follow up EGD with biopsies until 12 months after UEMR
Adverse events	Perforation 0% Delayed bleeding 1.2%
Outcome measures	Non recurrence rate 97.2%
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 26 Day
Date of IRB	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 03 Month 03 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Evaluate the efficacy of UEMR for SNADETS Evaluate the recurrence 2 month and 12 month after UEMR

Management information
Registered date	2017 Year 12 Month 15 Day
Last modified on	2021 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034729