UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028747
Receipt number R000032899
Scientific Title Efficacy of polyglycolic acid sheet and steroid injection for preventing stricture in sub-circumference ESD.
Date of disclosure of the study information 2017/08/21
Last modified on 2017/08/19 21:56:55

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Basic information

Public title

Efficacy of polyglycolic acid sheet and steroid injection for preventing stricture in sub-circumference ESD.

Acronym

PGA steroid study

Scientific Title

Efficacy of polyglycolic acid sheet and steroid injection for preventing stricture in sub-circumference ESD.

Scientific Title:Acronym

PGA steroid study

Region

Japan


Condition

Condition

Esophageal cancer including intraepithelial neoplasia

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Clarify prophylactic efficacy and safety of hybrid therapy using PGA sheet and steroid injection

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Stricture rate on 8 weeks after ESD

Key secondary outcomes

1 Numbar of balloon dilatation
2 adverse events
3 Stricture rate when ulceration healed to scar formation
4 Stricture rate on 6 months after ESD


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

Prevention

Type of intervention

Medicine

Interventions/Control_1

PGA sheet and steroid injection

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1 The patients predicted to resect with a mucosal defect greater than or equal to 5/6 of the esophageal circumference
2 Over 20 years old
3 obtain informed consent

Key exclusion criteria

1 Mucosal defect < 5/6 circumference
2 Entire circumferential lesion
3 Patients who resected entire curcumference
4 take oral steroid therapy
5 Mental disease
6 Pregnancy
7 Allergy for PGA or fibrin glue
8 other reasons which made the subject ineligible to participate in this study, at the discretion of the chief investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuaki Nagami

Organization

Osaka City University Graduate school of Medicine

Division name

Gastroenterology

Zip code


Address

1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan

TEL

06-6645-3811

Email

yasuaki-75@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuaki Nagami

Organization

Osaka City University Graduate school of Medicine

Division name

Gastroenterology

Zip code


Address

1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan

TEL

06-6645-3811

Homepage URL


Email

yasuaki-75@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate school of Medicine

Institute

Department

Personal name



Funding Source

Organization

Osaka City University Graduate school of Medicine

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

2017 Year 08 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

Open public recruiting

Date of protocol fixation

2017 Year 08 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 21 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

2017 Year 08 Month 19 Day

Last modified on

2017 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032899


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name