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
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
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
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
