UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030414
Receipt number 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 2021/12/18 15:44:38

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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 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 or person

Institute

Okayama University Hospital

Institute

Department

Personal name



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

Value
https://center6.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