UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028639
Receipt number R000032778
Scientific Title Clinical Efficacy of Polyglycolic Acid Sheet to Prevent Esophageal Stricture after Endoscopic Submucosal Dissection
Date of disclosure of the study information 2018/12/31
Last modified on 2017/08/11 14:09:57

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Basic information

Public title

Clinical Efficacy of Polyglycolic Acid Sheet to Prevent Esophageal Stricture after Endoscopic Submucosal Dissection

Acronym

Polyglycolic acid sheet after ESD

Scientific Title

Clinical Efficacy of Polyglycolic Acid Sheet to Prevent Esophageal Stricture after Endoscopic Submucosal Dissection

Scientific Title:Acronym

Polyglycolic acid sheet after ESD

Region

Asia(except Japan)


Condition

Condition

early esophageal neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This prospective cohort study examined the clinical efficacy of application of PGA sheet with fibrin glue for the prevention of esophageal stricture after ESD.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the prevalence of esophageal stricture at 8 weeks

Key secondary outcomes

dysphagia scoring scale at 4 weeks and the frequency of adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

PGA sheets

Interventions/Control_2

No PGA sheets

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

Patients who had a mucosal defect that involved more than three-quarters of the esophageal circumference

Key exclusion criteria

Paitnet with additional surgery

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name HYUK LEE

Organization

Samsung Medical Center

Division name

Department of Medicine

Zip code


Address

Iwron-dong 50, Gangnam-gu

TEL

82234103409

Email

leehyuk@skku.edu


Public contact

Name of contact person

1st name
Middle name
Last name HYUK LEE

Organization

Samsung Medical Center

Division name

Department of Medicine

Zip code


Address

Iwron-dong 50, Gangnam-gu

TEL

82234103409

Homepage URL


Email

leehyuk@skku.edu


Sponsor or person

Institute

Korean College of Helicobacter and Upper Gastrointestinal Research

Institute

Department

Personal name



Funding Source

Organization

Korean College of Helicobacter and Upper Gastrointestinal Research Foundation Grant, and from Samsung Medical Center grant [#OTC1602121].

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

Samsung Medical Center(Seoul)


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 31 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

Completed

Date of protocol fixation

2015 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 31 Day

Last follow-up date

2017 Year 06 Month 15 Day

Date of closure to data entry

2017 Year 07 Month 15 Day

Date trial data considered complete

2017 Year 08 Month 01 Day

Date analysis concluded

2017 Year 08 Month 05 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 11 Day

Last modified on

2017 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name