UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD(endoscopic submucosal dissection) of superficial esophageal cancers
Title of the study (Brief title)	The evaluation of prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD(endoscopic submucosal dissection) of superficial esophageal cancers
Region	Japan

Condition
Condition	superficial esophageal cancers
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD of superficial esophageal cancers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	To compare the treatment duration between 2 groups (the weekly group receive 40mg of triamcinolone acetonide weekly, the biweekly group receive 40mg of triamcinolone acetonide biweekly )
Key secondary outcomes	Frequency of EBD(endoscopic balloon dilations), Stricture rate, Frequency of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The weekly group receive 40mg of triamcinolone acetonide weekly
Interventions/Control_2	The biweekly group receive 40mg of triamcinolone acetonide biweekly
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	Relative adaptational lesion for ESD and more than 3/4 luminal circumferencial mucosal defect
Key exclusion criteria	1)Not acceptance to participate in the study 2)Allergy for triamcinolone acetonide 3)Severe DM or adrenal malfunction 4)Inappropriate for this trial
Target sample size	30

Research contact person
Name of lead principal investigator	Morita Yoshinori
Organization	Kobe University, School fo Medicine
Division name	Department of Gastroenterology
Address	7-5-1,kusunoki-cho,cho-ku,Kobe 650-0017 Japan.
TEL	0783826305
Email	ymorita@med.kobe-u.ac.jp

Public contact
Name of contact person	Morita Yoshinori
Organization	Kobe University, School fo Medicine
Division name	Department of Gastroenterology
Address	7-5-1,kusunoki-cho,cho-ku,Kobe 650-0017 Japan.
TEL	0783826305
Homepage URL
Email	ymorita@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University, School fo Medicine
Institute
Department

Funding Source
Organization	Kobe University, School fo Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 30 Day
Anticipated trial start date	2010 Year 09 Month 16 Day
Last follow-up date	2012 Year 01 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 05 Month 26 Day
Last modified on	2016 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006676