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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024384
Receipt No. 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 2018/06/22

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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
Email 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
Email kotaro@med.shimane-u.ac.jp

Sponsor
Institute Gastroenterology, Faculty of Medicine, Shimane University
Institute
Department

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
Email

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
Anticipated trial start date
2016 Year 10 Month 01 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
2016 Year 10 Month 12 Day
Last modified on
2018 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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