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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006327
Receipt No. R000007494
Scientific Title A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Date of disclosure of the study information 2011/09/15
Last modified on 2016/03/16

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Basic information
Public title A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Acronym A RCT of local steroid injection for prevention of post-ESD esophageal stenosis
Scientific Title A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Scientific Title:Acronym A RCT of local steroid injection for prevention of post-ESD esophageal stenosis
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The proportion of patients who need endoscopic dilatation for post-ESD esophageal stenosis
Key secondary outcomes 1. The frequency of the complication with local steroid injection
2. The frequency of the complication with endoscopic dilatation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Local steroid injection (Triamcinolone Acetonide) after ESD
Interventions/Control_2 No treatment after ESD
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with superficial squamous cell carcinoma whose mucosal defect after ESD is expected to be over three-fourths of the whole circumference (being highly associated with post ESD stenosis)
Key exclusion criteria Excluded if patients have:
1. previous therapy experience
2. steroid treatment for other diseases
3. esophageal adenocarcinoma
4. swallowing difficulty
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Takahashi
Organization Keiyukai Sapporo Hospital
Division name Dept. of Gastroenterology
Zip code
Address 1-1, Hondori 14 north, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL 011-863-2101
Email hiroaki@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Takahashi
Organization Keiyukai Sapporo Hospital
Division name Dept. of Gastroenterology
Zip code
Address 1-1, Hondori 14 north, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL 011-863-2101
Homepage URL
Email hiroaki@sapmed.ac.jp

Sponsor
Institute Dept. of Gastroenterology, Keiyukai Sapporo 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 恵佑会札幌病院(北海道)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25609176
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
2010 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 09 Month 12 Day
Last modified on
2016 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007494

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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