UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of diagnostic ability of endoscopic observational methods about demarcation of early eshophageal squamous cell carcinomas
Title of the study (Brief title)	Diagnosis of demarcation of early esophageal squamous cell carcinomas
Region	Japan

Condition
Condition	early esophageal squamous cell carcinoma
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare diagnostic ability of magnifying endoscopy with narrow band imaging and Lugol chromoendoscopy about demarcation of early esophageal squamous cell carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of accurate diagnosis of demarcation of early esophageal squamous cell carcinomas
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	marking dots for demarcation of tumors
Interventions/Control_2	marking dots for demarcation of tumors
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients of early eshophagel squamous cell carcinoma who will undergo endoscopic submucosal dissection at our hospital and gave written informed consent
Key exclusion criteria	patients of residual cancers after endoscopic resection patients whose cancer was resected in a piecemeal fashion
Target sample size	100

Research contact person
Name of lead principal investigator	Shinya Kodashima
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	kodashima-tky@umin.ac.jp

Public contact
Name of contact person	Itsuko Asada-Hirayama
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	ihirayama-tky@umin.ac.jp

Sponsor
Institute	the Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	Laboratory 108, the Department of Gastroenterology
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	2012 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 29 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry	2014 Year 05 Month 30 Day
Date trial data considered complete	2014 Year 06 Month 10 Day
Date analysis concluded	2014 Year 09 Month 30 Day

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

Management information
Registered date	2012 Year 04 Month 02 Day
Last modified on	2017 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008974