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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047432
Receipt No. R000054086
Scientific Title A multicenter randomized control trial comparing the resecion depth of underwater endoscopic resection and conventional endoscopic resection for colorectal tumors
Date of disclosure of the study information 2022/05/09
Last modified on 2022/04/07

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Basic information
Public title A multicenter randomized control trial comparing the resecion depth of underwater endoscopic resection and conventional endoscopic resection for colorectal tumors
Acronym RCT comparing the resecion depth of UEMR and EMR for colorectal tumors
Scientific Title A multicenter randomized control trial comparing the resecion depth of underwater endoscopic resection and conventional endoscopic resection for colorectal tumors
Scientific Title:Acronym RCT comparing the resecion depth of UEMR and EMR for colorectal tumors
Region
Japan

Condition
Condition Colorectal tumors 10mm - 20mm in diameter
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of UEMR for 10-20 mm colorectal tumors in comparison with those of conventional EMR
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Resection depth
Key secondary outcomes The proportion of the presence of the muscularis mucosa, en bloc resection rate, complete resection rate, curative resection rate, resection time, adverse events, the local recurrence rate one year after

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group A: EMR group
Interventions/Control_2 Group B: UEMR 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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Colorectal tumor 10 - 20 mm in diameter
2. Aged 20 to 90 years old.
3. PS (ECOG) performance status of 0,1or2.
4. Patients taking one antithrombotic drug.
5. Written informed consent
Key exclusion criteria 1. Pedunculated polyp or endospically suspected T1 cancer
2. local recurrence after endoscopic resection
3. Familial adenomatous polyposis and/or inflamatory bowel disease
4. Patients taking more than two kinds of antithrombotic drugs
5. Patients with thrombocytopenia and/or bleeding tendency
6. Women during pregnancy
7. Patients enrolled in this study
8. Unsuitable patient for clinical trial judged by clinicians
Target sample size 230

Research contact person
Name of lead principal investigator
1st name Toshio
Middle name
Last name Kuwai
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyama-cho, Kure, Japan
TEL +81-823-22-3111
Email kuwai.toshio.ur@mail.hosp.go.jp

Public contact
Name of contact person
1st name Yuzuru
Middle name
Last name Tamaru
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyama-cho, Kure, Japan
TEL +81-823-22-3111
Homepage URL
Email tamaru.yuzuru.vh@mail.hosp.go.jp

Sponsor
Institute Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department

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 National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Address 3-1 Aoyama-cho, Kure, Japan
Tel +81-823-22-3111
Email tamaru.yuzuru.vh@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 09 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 Preinitiation
Date of protocol fixation
2022 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 01 Day
Last follow-up date
2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 04 Month 07 Day
Last modified on
2022 Year 04 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054086

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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