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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027638
Receipt No. R000031663
Scientific Title Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/05

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Basic information
Public title Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study
Acronym Two Electrosurgical Mode for Colorectal ESD
Scientific Title Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study
Scientific Title:Acronym Two Electrosurgical Mode for Colorectal ESD
Region
Japan

Condition
Condition Colorectal Superficial Neoplasms:
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compared the performances of the Endo-cut I mode and Swift-coagulation mode
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes procedure time required for submucosal dissection
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 performed ESD with Endo-cut I mode
Interventions/Control_2 performed ESD with Swift-coagulation mode
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 (a)tumour diagnosed with colonoscopy before ESD
(b)lesions of 20-50 mm in diameter
(c)colorectal intra-mucosal or minutes-invaded cancer
(d)no lymph node or distant metastasis
Key exclusion criteria (a) non-correctable coagulopathy
(b) severe organ failure
(c) a comorbidity requiring continuous antithrombotic medication
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keita Harada
Organization Okayama University Graduate School of Medicine
Division name Division of Endoscopy
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7219
Email keita818@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuusaku Sugihara
Organization Okayama University Graduate School of Medicine
Division name general medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7219
Homepage URL
Email y.sugi117@gmail.com

Sponsor
Institute Division of Endoscopy
Okayama University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2017 Year 07 Month 01 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
2017 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 05 Day
Last modified on
2017 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031663

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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