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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018989
Receipt No. R000021963
Scientific Title A comparative study to assess the safety and efficacy of underwater EMR for intermediate size (10-20 mm) colorectal polyps.
Date of disclosure of the study information 2015/09/12
Last modified on 2019/05/07

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Basic information
Public title A comparative study to assess the safety and efficacy of underwater EMR for intermediate size (10-20 mm) colorectal polyps.
Acronym UEMR vs C-EMR study
Scientific Title A comparative study to assess the safety and efficacy of underwater EMR for intermediate size (10-20 mm) colorectal polyps.
Scientific Title:Acronym UEMR vs C-EMR study
Region
Japan

Condition
Condition Sessile colorectal polys 10mm - 20mm in diameter.
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of UEMR for 10-20 mm sessile colorectal polyp in comparison with those of conventional EMR
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Histologic complete resection rate
Key secondary outcomes Endoscopic complete resection rate, R0 resection rate, Adverse events, Total procedure time, The incidende of residual poyp on follow-up colonoscopy 12 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Underwater EMR group
Interventions/Control_2 Conventional EMR group
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)Patients undergoing colorectal polypectomy (polyps < 10mm)
2) Written Informed consent.
3) 20 y.o. <
Key exclusion criteria 1)pedunculated polyp
2)residual lesions after EMR
3)patients with marked electrolyte abnormality
4)patients with hematological abnormality
5)patients with severe organ failure
6) patients with inflammatory bowel disease and polyposis
7) patients who have been judged as inappropriate for this study
Target sample size 230

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 3-1-69, Ohtemae, Chuo-ku, Osaka 541-8567, Japan.
TEL 06-6945-1181
Email uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Iwatsubo taro
Organization Osaka international cancer institute
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka, Japan
TEL 06-6945-1181
Homepage URL
Email iwatubo-ta@mc.pref.osaka.jp

Sponsor
Institute Osaka international cancer institute
Institute
Department

Funding Source
Organization None

Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese Red Cross Osaka Hospital
Japanese Red Cross Society Wakayama Medical Center
Kyoto Second Red Cross Hospital
Kyoto Katsura Hospital
Wakayama Medical University
Osaka National Hospital
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 大阪国際がんセンター(大阪府)、大阪赤十字病院(大阪府)、日本赤十字社和歌山医療センター(和歌山県)、京都第二赤十字病院(京都府)、京都桂病院(京都府)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 12 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 Main results already published
Date of protocol fixation
2015 Year 08 Month 11 Day
Date of IRB
2015 Year 08 Month 11 Day
Anticipated trial start date
2015 Year 09 Month 14 Day
Last follow-up date
2019 Year 01 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 12 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021963

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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