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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001302
Receipt No. R000001579
Scientific Title Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Date of disclosure of the study information 2008/08/20
Last modified on 2015/10/20

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Basic information
Public title Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Acronym Device selection RCT in colorectal ESD.
Scientific Title Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Scientific Title:Acronym Device selection RCT in colorectal ESD.
Region
Japan

Condition
Condition colorectal epitherial neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Flush knife compared with Flex knife in colorectal ESD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Procedure time
Key secondary outcomes

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Flex knife group
Interventions/Control_2 Flush knife 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Intramucosal or minutes submucosal invaded (SM1) colorectal epitherial neoplasms which are larger than 20mm and smaller than 60mm.
Key exclusion criteria 1) SM massive cancer
2) Lesions which are existed on anal canal or in cecum.
3) Patients with hematological abnormality.
4) Patients with severe organ failure
5) Patients without written informed consent
6) Lesions which were thought to be difficult to resect by ESD because of unstable positioning of colonoscope.
7) Others who were thought to be unsuitable by endoscopist.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoji Takeuchi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address 3-3 Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL 06-6972-1181
Email takeuti-yo@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoji Takeuchi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address 1-3-3 Nakamichi Higashinari-ku, Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email takeuti-yo@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
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
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
2008 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/ajg/journal/vaop/ncurrent/abs/ajg2009547a.html
Number of participants that the trial has enrolled
Results
Without increasing adverse events, the endo-knife with a water-jet function efficiently reduced the operation time of colorectal ESD in patients with large superficial neoplasms. 
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
2008 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 06 Day
Last modified on
2015 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001579

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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