UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of polyglycolic acid sheet and steroid injection for preventing stricture in circumferential ESD.
Title of the study (Brief title)	PGA steroid in circumferential ESD
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	Safety,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 entire circumference mucosal defect 2 Over 20 years old 3 obtain informed consent
Key exclusion criteria	1 Without entire circumferential mucosal defect 2 take oral steroid therapy 3 Mental disease 4 Pregnancy 5 Allergy for PGA or fibrin glue 6 other reasons which made the subject ineligible to participate in this study, at the discretion of the chief investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	Yasuaki Nagami
Organization	Osaka City University Graduate school of Medicine
Division name	Gastroenterology
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	Yasuaki Nagami
Organization	Osaka City University Graduate school of Medicine
Division name	Gastroenterology
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
Institute	Osaka City University Graduate school of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032900