UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surveillance for esophageal cancer using NBI endoscopy
Title of the study (Brief title)	NBI surveillance
Region	Japan

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

Objectives
Narrative objectives1	We investigate whether scheduled endoscopic surveillance is sufficient to identify metachronous cancer earlier enough for curative treatment by endoscopic resection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5 years control rate by endoscopic surveillance and endoscopic resection
Key secondary outcomes	incident rate of metachronous esophageal cancer, 5 years survival rate, accuracy of magnified NBI endoscopy, clinical and pathological characteristics of metachronous esophageal cancer

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Magnified NBI endoscopy
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	patients who received endoscopic resection for esophagealcancer and diagnosed curative resection within depth of T1a-LPM.
Key exclusion criteria	(1) esophageal and pharyngeal stricture (2) previous surgical resection or chemotherapy, radiotherapy, or chemoradiotherapy for esophageal SCC (3) patients with active malignant cancer or presence of serious complications (liver, kidney, heart, blood, or metabolic disorders) (4) other reasons which made the subject ineligible to participate in this study, at the discretion of the chief investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuaki Nagami
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL	06-6645-3811
Email	m1151493@med.osaka-cu.ac.jp

Public contact
Name of contact person	Yasuaki Nagami
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL	06-6645-3811
Homepage URL
Email	m1151493@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka City University Graduate School of 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	大阪市立大学医学部附属病院　消化器内科

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 12 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 31 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
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

Management information
Registered date	2014 Year 04 Month 12 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015994