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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005546
Receipt No. R000006553
Scientific Title Effect of applyed steroid gel on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early esophageal cancer -Preventing esophageal stricture due to scar formation during the epithelial regeneration process
Date of disclosure of the study information 2011/05/06
Last modified on 2013/12/05

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Basic information
Public title Effect of applyed steroid gel on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early esophageal cancer
-Preventing esophageal stricture due to scar formation during the epithelial regeneration process
Acronym kenacort for the esophagus
Scientific Title Effect of applyed steroid gel on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early esophageal cancer
-Preventing esophageal stricture due to scar formation during the epithelial regeneration process
Scientific Title:Acronym kenacort for the esophagus
Region
Japan

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

Objectives
Narrative objectives1 A prospective study on preventing esophageal stricture by applying of kenacort gel following endoscopic submucosal dissection for esophagealcancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measured stenosis area by using esophagography at the right anterior oblique position
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Applying 2 vials of Kenacort(50mg/5ml/V) with endolubri jelly(7.5ml) on the day of endoscopic mucosal dissection(postoperative Day 5,Day 8,Day12,Day15,Day20)
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
30 years-old <=
Age-upper limit
95 years-old >
Gender Male and Female
Key inclusion criteria Patients with early esophageal cancer scheduled for endoscopic submucosal dissection from whom informed consent was obtained
Key exclusion criteria Post operative esophagus
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Mori
Organization Kagawa university
Division name Department of gastroenterology and neurology
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture,761-0793 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagawa university
Division name Department of gastroenterology
Zip code
Address
TEL 087-891-2156
Homepage URL
Email

Sponsor
Institute Kagawa university
Institute
Department

Funding Source
Organization Kagawa university
Organization
Division
Category of Funding Organization
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
2011 Year 05 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This study was integrated UMIN000003762
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
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
2010 Year 05 Month 10 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 05 Month 02 Day
Last modified on
2013 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006553

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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