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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014642
Receipt No. R000017034
Scientific Title Study of combination therapy with endoscopic triamsinolone injection and polyglycolic acid sheet for the prevention of esophageal stricture after endoscopic submucosal dissection
Date of disclosure of the study information 2014/07/25
Last modified on 2016/01/29

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Basic information
Public title Study of combination therapy with endoscopic triamsinolone injection and polyglycolic acid sheet for the prevention of esophageal stricture after endoscopic submucosal dissection
Acronym Study of combination therapy with endoscopic triamsinolone injection and polyglycolic acid sheet for the prevention of esophageal stricture after endoscopic submucosal dissection
Scientific Title Study of combination therapy with endoscopic triamsinolone injection and polyglycolic acid sheet for the prevention of esophageal stricture after endoscopic submucosal dissection
Scientific Title:Acronym Study of combination therapy with endoscopic triamsinolone injection and polyglycolic acid sheet for the prevention of esophageal stricture after endoscopic submucosal dissection
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of combination therapy with endoscopic triamsinolone injection and polyglycolic acid sheetfor the prevention of esophageal stricture after endoscopic submucosal dissection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of esophageal stricture
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination therapy with endoscopic triamsinolone injection and polyglycolic acid sheet
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 Patient who will be performed endoscopic treatment for esophageal cancer. Absolute or relative indication of endoscopic treatment within the therapy guidelines for esophageal cancer.
ESD is planned for esophageal cancer, and expected to result of a size of more than 1/2 luminal circumferencial esophageal cancer.
ECOG Performance status 0-2.
Aged upper 20 years old.
Written informed consent.
Key exclusion criteria Active infection.
Patients with continuous systemic steroids medication.
Psychosis. Patients who have been judged as inappropriate for this study.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Doyama
Organization Ishikawa prefectural central hospital
Division name Department of Gastroenterology
Zip code
Address 2-1 Kuratukihigashi Kanazawa-shi Ishikawa-ken
TEL 076-237-8211
Email doyama.134@ipch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Tsuji
Organization Ishikawa prefectural central hospital
Division name Department of Gastroenterology
Zip code
Address 2-1 Kuratukihigashi Kanazawa-shi Ishikawa-ken
TEL 076-237-8211
Homepage URL
Email m92162g@ipch.jp

Sponsor
Institute Ishikawa prefectural central hospital
Institute
Department

Funding Source
Organization None
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
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
2014 Year 07 Month 25 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 Terminated
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 25 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
2014 Year 07 Month 24 Day
Last modified on
2016 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017034

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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