UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024384 |
|---|---|
| Receipt number | R000028066 |
| Scientific Title | Clinical efficacy of triamcinolone acetonide-filling method for the prevention of esophageal stenosis after subcircumferential or circumferential ESD (multicenter phase II study) |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2020/04/20 08:13:24 |
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Basic information
Public title
Clinical efficacy of triamcinolone acetonide-filling method for the prevention of esophageal stenosis after subcircumferential or circumferential ESD (multicenter phase II study)
Acronym
esophageal triamcinolone acetonide-filling method
Scientific Title
Clinical efficacy of triamcinolone acetonide-filling method for the prevention of esophageal stenosis after subcircumferential or circumferential ESD (multicenter phase II study)
Scientific Title:Acronym
esophageal triamcinolone acetonide-filling method
Region
| Japan |
Condition
Condition
superficial esophageal carcinoma requiring 3/4 round or more resection by ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy and safety of the esophageal triamcinolone acetonide (TA)-filling method in the prevention of esophageal stenosis after subcircumferential and circumferential ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of severe stenosis
Key secondary outcomes
A total number of Endoscopic balloon dilatation (EBD) and additional TA-filling procedure, dysphagia score, complete re-epithelialization time without stenosis, and other 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
no control (single arm)
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)Endoscopically diagnosed as the superficial esophageal cancer with a half of circumference or more .
2)Neither lymph nor distant metastasis was recognized by X-ray, abdominal ultrasonography, endoscopic ultrasonography, and computed tomography.
3)Post-ESD ulcer is expected to reach three quater or more.
4)Prognosis is expected to be improved by endoscopic resection of the lesion.
5)General status is expected to be tolerant of general or intravenouos anesthesia.
6)Patient agree with the participation in the study.
Key exclusion criteria
1)severe infection of pharyngolarynx or esophagus.
2)high risk of drug aspiration due to the vocal code paralysis or dysphagea.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Shibagaki |
Organization
Shimane University Hospital
Division name
Gastroenterology
Zip code
Address
89-1 Enya, Izumo, Japan
TEL
+81-85320-2190
kotaro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Shibagaki |
Organization
Shimane University Hospital
Division name
Gastroenterology
Zip code
Address
89-1 Enya, Izumo, Japan
TEL
+81-85320-2190
Homepage URL
kotaro@med.shimane-u.ac.jp
Sponsor or person
Institute
Gastroenterology, Faculty of Medicine, Shimane University
Institute
Department
Personal name
Funding Source
Organization
No fund.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 20 | 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 | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028066
