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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016178
Receipt No. R000003937
Scientific Title Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection.
Date of disclosure of the study information 2015/01/11
Last modified on 2015/01/11

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Basic information
Public title Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection.
Acronym Post-ESD esophageal strictures and prednisolone
Scientific Title Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection.
Scientific Title:Acronym Post-ESD esophageal strictures and prednisolone
Region
Japan

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

Objectives
Narrative objectives1 Effectiveness of prednisolone oral administration for esophageal strictures after endoscopic submucosal dissection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes prevention of esophageal stricture
presence of the stricture-related symptoms
Key secondary outcomes times of preventive endoscopic balloon dilatation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral prednisolone
Interventions/Control_2
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 inidication for ESD
no related complications
Key exclusion criteria presence of related complications
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Isomoto
Organization Nagasaki University Hospital
Division name Endoscopy
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7336
Email hajimei2002@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Isomoto
Organization Nagasaki University Hospital
Division name Endoscopy
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7336
Homepage URL
Email hajimei2002@yahoo.co.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki University Hospital
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
2015 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 26 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
2015 Year 01 Month 11 Day
Last modified on
2015 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003937

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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