UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of endoscopic resection for duodenal tumors; a single center prospective study
Acronym	Efficacy of endoscopic resection for duodenal tumors
Scientific Title	Efficacy of endoscopic resection for duodenal tumors; a single center prospective study
Scientific Title:Acronym	Efficacy of endoscopic resection for duodenal tumors
Region	Japan

Condition
Condition	Duodenal tumors
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The feasibility of endoscopic resection for duodenal tumors is evaluated in a clinical study
Basic objectives2	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

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Endoscopic resection
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	Not applicable
Gender	Male and Female
Key inclusion criteria	This study involves patients who undergo endoscopic resection for duodenal tumors.
Key exclusion criteria	Patients whose lesions are found to invade submucosal layer by the preceding endoscopic check up before treatment, Patients who are stopped for an unavoidable reason during treatment
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Naohisa Middle name Last name Yahagi
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3914
Email	yahagi.keio@gmail.com

Public contact
Name of contact person	1st name Motohiko Middle name Last name Kato
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3914
Homepage URL
Email	moto28hiko@icloud.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University 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)

IRB Contact (For public release)
Organization	Research ethics committee, Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-5363-3914
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 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	Completed
Date of protocol fixation	2016 Year 10 Month 31 Day
Date of IRB	2016 Year 10 Month 31 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry	2020 Year 06 Month 30 Day
Date trial data considered complete	2020 Year 06 Month 30 Day
Date analysis concluded	2020 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 12 Month 27 Day
Last modified on	2020 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029260