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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033156
Receipt No. R000037810
Scientific Title Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Date of disclosure of the study information 2018/06/27
Last modified on 2018/06/27

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Basic information
Public title Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Acronym Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Scientific Title Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Scientific Title:Acronym Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Region
Japan

Condition
Condition early esophageal squamous cell carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the performances of two endo-knives for traction-assisted endoscopic submucosal dissection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedure time required for endoscopic 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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 esophageal ESD with Dual knife
Interventions/Control_2 esophageal ESD with IT knife nano
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
85 years-old >=
Gender Male and Female
Key inclusion criteria (1) The patients scheduled for esophageal ESD
(2) with informed consent
Key exclusion criteria (1) Previous surgery in esophagus
(2) Chemoradiotherapy for early esophageal squamous cell carcinoma
(3) Lesions located 10 mm within previous endoscopic resection scar
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyasu Kitagawa
Organization Chiba Cancer Center
Division name Endoscopy division
Zip code
Address 666-2 Nitonacho, Chuo-ku, Chiba, Japan
TEL 043-264-5431
Email ykitagawa@chiba-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyasu Kitagawa
Organization Chiba Cancer Center
Division name Endoscopy division
Zip code
Address 666-2 Nitonacho, Chuo-ku, Chiba, Japan
TEL 043-264-5431
Homepage URL
Email ykitagawa@chiba-cc.jp

Sponsor
Institute Chiba Cancer Center
Institute
Department

Funding Source
Organization Chiba Cancer Center
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
2018 Year 06 Month 27 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 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
2018 Year 06 Month 27 Day
Last modified on
2018 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037810

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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