UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 06 Month 05 Day
Date of IRB	2020 Year 11 Month 06 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2020 Year 11 Month 06 Day
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	2020 Year 11 Month 06 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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