UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018710
Receipt number R000021649
Scientific Title Feasibility of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors
Date of disclosure of the study information 2015/08/18
Last modified on 2016/09/12 14:30:52

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Basic information

Public title

Feasibility of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors

Acronym

Feasibility of UEMR for nonampullary duodenal tumors

Scientific Title

Feasibility of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors

Scientific Title:Acronym

Feasibility of UEMR for nonampullary duodenal tumors

Region

Japan


Condition

Condition

duodenal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the utility and safety of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Pathological complete resection rate
(completeness of resection on follow-up
endoscopy)

Key secondary outcomes

Endoscopic complete resection rate, R0 resection rate, Procedure time, Total procedure time, Total amount of infusion water, Adverse events


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

1:Nonampullary duodenal tumors that can be removed endoscopically
2:Adenoma or Intramucosal cancer

Key exclusion criteria

1:ampullary tumor
2:tumors that are difficult to remove endoscopically
3:invasive cancer
4:residual lesions after EMR
5:patients with FAP or Lynch syndrome
6:patients with hematological abnormality
7:patients with severe organ failure
8:patients who have been judged as in appropriate for this study

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriya Uedo

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gastrointestinal Oncology

Zip code


Address

1-3-3, Higashinari-ku, Osaka 537-8511, Japan

TEL

+81-6-6972-1181

Email

uedou-no@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Yamasaki

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gastrointestinal Oncology

Zip code


Address

1-3-3, Higashinari-ku, Osaka 537-8511, Japan

TEL

+81-6-6972-1181

Homepage URL


Email

yasshifive@yahoo.co.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

None

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



Other administrative information

Date of disclosure of the study information

2015 Year 08 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

Completed

Date of protocol fixation

2015 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 19 Day

Last follow-up date

2016 Year 09 Month 12 Day

Date of closure to data entry

2016 Year 09 Month 12 Day

Date trial data considered complete

2016 Year 09 Month 12 Day

Date analysis concluded

2016 Year 09 Month 30 Day


Other

Other related information

A follow up EGD 3 month after duodenal UEMR should be performed.


Management information

Registered date

2015 Year 08 Month 18 Day

Last modified on

2016 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021649


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name