UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025447 |
|---|---|
| Receipt number | R000029060 |
| Scientific Title | A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E) |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2021/07/01 17:03:19 |
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Basic information
Public title
A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Acronym
A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Scientific Title
A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Scientific Title:Acronym
A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Region
| Japan |
Condition
Condition
Early stage esophageal cancer after entire circumferential endoscopic submucosal dissection (ESD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic acid and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of stenosis after ESD
Key secondary outcomes
The number and period of endoscopic dilation, the coverage rate, the time of cover the mucosal defect, PGA sheets residual rate one week later, the number of endoscopic dilation of 12 weeks after ESD, stricture-free survival of 12 weeks after ESD, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Local sterid (triamcinolone acetonide 100mg) injection and shielding with polyglycolic acid sheets and fibrin glue to the mucosal defect immediately after ESD.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Be expected to become entire circumferential mucosal defect after esophageal ESD
2) Over the age of 20
3) Dysphagia score of 0
4) Written informed consent
Key exclusion criteria
1) Active infection requiring systemic therapy
2) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding
3) Hypersensitivity for triamcinolone acetone
4) Severe psychiatric disease
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kawata |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL
055-989-5222
n.kawata@scchr.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Kawata |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL
055-989-5222
Homepage URL
n.kawata@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
Tel
055-989-5222
n.kawata@scchr.jp
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 | 01 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029060
