UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Standardization of safer doudenal ESD: analysis observation study of typical procedure of duodenal ESD
Title of the study (Brief title)	Standardization of safer doudenal ESD
Region	Japan

Condition
Condition	Duodenal adenoma or cancer
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of combination ESD using pre-clipping method, ring thread countertraction method and closure of the Over The Scope Clip
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perforation rate during duodenal ESD
Key secondary outcomes	Bleeding rate Procedure time Delayed perforation

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Ring shaped counter traction
Interventions/Control_2	OTSC
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	25 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria 75 patient who are diagnosed with duodenal adenoma or early duodenal cancer (over 20mm in diameter) and performed ESD.
Key exclusion criteria	Exclusion criteria 1.Diagnosed with Diabetes Mellitus 2.Taking Steroid or immune suupress drugs 3.Chr.pancreatitis
Target sample size	75

Research contact person
Name of lead principal investigator	Hirohito Mori
Organization	Ehime Rosai Hospital
Division name	Department of Gastroenterology
Address	13-27, minami komatubara, niihama, Ehime, Japan
TEL	0897-33-6191
Email	hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person	Hirohito Mori
Organization	Ehime Rosai Hospital
Division name	Department of Gastroenterology
Address	13-27, minami komatubara, niihama, Ehime, Japan
TEL	0897-33-6191
Homepage URL
Email	hiro4884@med.kagawa-u.ac.jp

Sponsor
Institute	Ehime Rosai Hospital
Institute
Department

Funding Source
Organization	Ehime Rosai Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Ehime Rosai Hospital

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	82,83
Org. issuing International ID_1	Ehime Rosai Hospital
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 02 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 02 Month 14 Day
Last follow-up date
Date of closure to data entry	2017 Year 12 Month 27 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	From ethical point of view, investigation are performed

Management information
Registered date	2017 Year 02 Month 17 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030085