UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000021963