UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016178
Receipt number 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 22:07:11

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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 or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



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

Value
https://center6.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