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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030414
Receipt No. R000034729
Scientific Title Efficacy of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors (<=20 mm): a multicenter observational study
Date of disclosure of the study information 2017/12/18
Last modified on 2018/05/16

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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
Middle name
Last name Hiroyuki Okada
Organization Okayama University Hospital
Division name Department of Gastroenterology
Zip code
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
Middle name
Last name Yasushi Yamasaki
Organization Okayama University Hospital
Division name Department of Gastroenterology
Zip code
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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
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
2018 Year 05 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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