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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003762
Receipt No. R000004556
Scientific Title Effect of local steroid injection or application on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage esophageal cancer - Preventing esophageal stenosis due to scar formation during the epithelial regeneration process
Date of disclosure of the study information 2010/06/15
Last modified on 2016/08/15

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Basic information
Public title Effect of local steroid injection or application on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage esophageal cancer
- Preventing esophageal stenosis due to scar formation during the epithelial regeneration process
Acronym Kenacort injection or application for the esophagus
Scientific Title Effect of local steroid injection or application on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage esophageal cancer
- Preventing esophageal stenosis due to scar formation during the epithelial regeneration process
Scientific Title:Acronym Kenacort injection or application for the esophagus
Region
Japan

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

Objectives
Narrative objectives1 Local steroid injection or application therapy is effective for preventing esophageal stricture after endoscopic submucosal dissection (ESD). We evaluated the effectiveness of triamcinolone acetonide (TA) application followed by balloon dilatation compared to steroid injection and application following endoscopic submucosal dissection for esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome measure was the difference in stricture rate between groups determined by gastrografin esophagograms on PODs 5, 8, 12, 15, 20, 30, and 60 between 2 gouups.
Key secondary outcomes The number of EBD procedures, the number of procedure-related bleeding events

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment Maneuver
Interventions/Control_1 In the local steroid injection group, 0.2 ml (2 mg) TA was locally injected into the ulcer floor at 8 mm intervals with extra care to avoid injection and following 5 min balloon dilatation (12-15 mm in diameter) was performed on PODs 5, 8, 12, and 15. Gastrografin esophagograms was also taken on PODs 5, 8, 12, 15, 20, 30, and 60. The 45-degree RAO position to evaluate esophageal stricture.
Interventions/Control_2 In the steroid gel application group on each PODs 5, 8, 12, and 15 triamcinolone acetonide (TA) gel was locally applied onto the ulcer floor and following balloon dilatation was performed immediately. The TA gel was made and applied as follows: total of 10 ml TA (100 mg) was mixed with 7.5 ml Endolubri jelly to make 17.5 ml of gel
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with early-stage esophageal cancer who had undergone endoscopic submucosal dissection with an excision of three fourths to the full circumference of the esophagus from whom informed consent was obtained
Key exclusion criteria nothing in particular
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Mori
Organization Kagawa University
Division name Department of gastroenterology
Zip code
Address 1750-1 ooaza ikenobe miki town kida county kagawa prefecture
TEL 087-891-2156
Email hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Fujhara
Organization Kagawa University
Division name Department of gastroenterology
Zip code
Address 1750-1 ooaza ikenobe miki town kida county kagawa prefecture
TEL 087-891-2156
Homepage URL
Email joshin@med.kagawa-u.ac.jp

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
2010 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2009 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2016 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study (UMIN000005546,3743) was reregistered and was discontinued.
This study was original version.

Management information
Registered date
2010 Year 06 Month 15 Day
Last modified on
2016 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004556

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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