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
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
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
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
