UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	A prospective study on preventing stomach deformation by local injection of Kenacort following endoscopic submucosal dissection for gastric cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distance between marking clips placed on either side of the ulcer in the direction of short axis and length of the short axis
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Local injection of 2 vials of Kenacort (50 mg/5 mL/V) on the day of endoscopic submucosal dissection (postoperative Day 0), Day 5, and Day 12
Interventions/Control_2	EGD were performed 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	30 years-old <=
Age-upper limit	95 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with early gastric cancer scheduled for endoscopic submucosal dissection from whom informed consent was obtained
Key exclusion criteria	Post operative stomach
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name mori hirohito
Organization	Kagawa university
Division name	Department of gastroenterology
Zip code
Address	1750-1 ooaza ikenobe miki town kida county kagawa prefecture
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	2010 Year 06 Month 12 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	Completed
Date of protocol fixation	2010 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date	2010 Year 06 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	2010 Year 06 Month 12 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=R000004534

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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