UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of endoscopic resection for early gastrointestinal neoplasms
Acronym	KEIO-GI study
Scientific Title	Prospective observational study of endoscopic resection for early gastrointestinal neoplasms
Scientific Title:Acronym	KEIO-GI study
Region	Japan

Condition
Condition	Early gastrointestinal neoplasms
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the feasibility of endoscopic resection for early gastrointestinal neoplasms
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Five-year relapse-free survival rate
Key secondary outcomes	Procedure success rate, En bloc resection rate, Pathological diagnosis, Complications, Procedure time, Amount of bleeding, Three-year relapse-free survival rate, Relapse-free survival time, Three or five-year overall survival rate, Quality of life after procedure, Medical care cost

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	Patients who undergo endoscopic resection for early gastrointestinal neoplasms
Key exclusion criteria	Patients whose lesions were found to be outside the adaptation for endoscopic resection
Target sample size	1500

Research contact person
Last name of lead principal investigator	1st name Kato Middle name Last name Motohiko
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3437
Email	motohikokato@keio.jp

Public contact
1st name of contact person	1st name Kiguchi Middle name Last name Yoshiyuki
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3437
Homepage URL
Email	kiguchiyoshiyuki@keio.jp

Sponsor
Institute	Keio University School of Medicine
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)

IRB Contact (For public release)
Organization	Research ethics committee, Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	0333531211
Email	med-rinri-jimu@adst.keio.ac.jp

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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 01 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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 19 Day
Date of IRB	2018 Year 12 Month 12 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2029 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: Prospective observational study Aim: To clarify the feasibility of endoscopic resection for early gastrointestinal neoplasms

Management information
Registered date	2018 Year 12 Month 04 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040041