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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034207
Receipt No. R000038813
Scientific Title The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial
Date of disclosure of the study information 2018/09/21
Last modified on 2018/09/20

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Basic information
Public title The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial
Acronym The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial
Scientific Title The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial
Scientific Title:Acronym The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial
Region
Japan

Condition
Condition esophageal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the association between quantity of electricity during ESD and postoperative esophageal stricture formation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stenosis rate of esophagus after esophageal ESD
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Low set point of high frequency energy output device
Interventions/Control_2 Normal set point of high frequency energy output device
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Esophagus tumor which meet indication of esophageal ESD
Key exclusion criteria 1)Patients under the pregnancy or with a history of drug allergy
2)Patients with a serious organ disorder
3)Patients with active infection
4)Post-ESD artificial ulcer of a size of not less than three-forth of the circumference
5)Patients with more than 2 lesions
6)major axis > 50mm
7)A lesion is located in cervical or abdominal esophagus
8)Invasion depth > SM, ly+, V+, HM+, VM+
9)Patients needs prevension therapy (local steroid injection)
10)Patients under steroid treatment
11)Patients with serious complication
12)Patients who are disqualified for the study by medical doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University Hospital
Division name Esophageal-Gastro-Intestinal Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-226-2109
Email matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Yamaguchi
Organization Chiba University Hospital
Division name Esophageal-Gastro-Intestinal Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-226-2109
Homepage URL
Email adta4613@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Esophageal-Gastro-Intestinal Surgery
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
2018 Year 09 Month 21 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
2018 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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 09 Month 20 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038813

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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