UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk factors for strictures after esophageal ESD:a prospective single-arm observational study
Title of the study (Brief title)	Risk factors for strictures after esophageal ESD:a prospective single-arm observational study
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the risk factors of strictures after esophageal ESD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between ESD strictures and ESD ulcers factors
Key secondary outcomes	A frequency of balloon dilatation for ESD strictures Restructure-free period Adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	After esophageal endoscopic submucosal dissection Intralesional steroid injection to prevent stricture after endoscopic submucosal dissection for esophageal cancer No history of esophagectomy Written informed consent
Key exclusion criteria	No infection No possibility for pregnancy No oral steroid intake or immunosuppressive agents
Target sample size	210

Research contact person
Name of lead principal investigator	Ryu Ishihara
Organization	Osaka International Cancer Institute
Division name	Dept. of Gastrointestinal Oncology
Address	3-1-69 Otemae Chuoku Osaka
TEL	+81-6-6945-1181
Email	isihara-ry@mc.pref.osaka.jp

Public contact
Name of contact person	Noriko Matsuura
Organization	Osaka International Cancer Institute
Division name	Dept. of Gastrointestinal Oncology
Address	3-1-69 Otemae Chuoku Osaka
TEL	+81-6-6945-1181
Homepage URL
Email	ibura9@yahoo.co.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Self funding
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	2017 Year 08 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 11 Day
Anticipated trial start date	2017 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The aim of this observational study is to investigate the risk factors of ESD strictures after intralesional steroid injections.

Management information
Registered date	2017 Year 08 Month 29 Day
Last modified on	2017 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033067