UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of narrow and ball tipped knife with water jet function for colorectal endoscopic submucosal dissection
Title of the study (Brief title)	Efficacy of narrow knife for colorectal ESD
Region	Japan

Condition
Condition	Colorectal polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the efficacy of narrow knife for colorectal ESD with respect to vacuum function, water jet function, and knife insertion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of vacuum function in basic and clinical research
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases with adenoma and early cancer 20-50mm in size
Key exclusion criteria	Cases with serious dysfunction of main organs
Target sample size	30

Research contact person
Name of lead principal investigator	Naohisa Yoshida
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5519
Email	naohisa@koto.kpu-m.ac.jp

Public contact
Name of contact person	Naohisa Yoshida
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5519
Homepage URL
Email	naohisa@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kobe University Hospital
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	京都府立医科大学附属病院(京都府)、神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 01 Month 30 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To analyze the efficacy of narrow knife for colorectal ESD with respect to vacuum function, water jet function, and knife insertion.

Management information
Registered date	2017 Year 01 Month 30 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029775