UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of underwater endoscopic mucosal resection for flat gastrointestinal polyps
Title of the study (Brief title)	Feasibility of UEMR for flat gastrointestinal polyps
Region	Japan

Condition
Condition	flat gastrointestinal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of UEMR for flat gastrointestinal polyps
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological complete resection rate
Key secondary outcomes	Endoscopic complete resection rate, Procedure time, Total amount of infusion water, Adverse events, local recurrence rate (follow up: 1 year after UEMR)

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	To perform UEMR for flat gastrointestinal polyps
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	1)Written informed consent 2)Patients (20-80 years old) with flat gastrointestinal polyps regardless of gender
Key exclusion criteria	1) Pedunclated polyp 2) Patients with marked electrolyte abnormality 3) Patients with severe organ failure 4) Patients who have been judged as inappropriate for this study
Target sample size	40

Research contact person
Name of lead principal investigator	Tetsuji Takayama
Organization	Tokushima University
Division name	Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	088-633-7124
Email	takayama@tokushima-u.ac.jp

Public contact
Name of contact person	Koichi Okamoto
Organization	Tokushima University
Division name	Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	088-633-7124
Homepage URL
Email	nontarou@tokushima-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University
Organization
Division
Category of Funding Organization	Other
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	2017 Year 04 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date
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	2017 Year 04 Month 08 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030864