UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized trial analysing the efficacy of hyaluronic acid and normal saline in colonic endoscopic mucosal resection
Title of the study (Brief title)	The RCT analyzing the efficacy of hyaluronic acid in colonic EMR
Region	Japan

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

Objectives
Narrative objectives1	The aim of this RCT is to evaluate the efficacy of hyarulonic acid in endoscopic mucosal resection for colorectal tumors compared to normal saline
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The rate of endoscopic and histopathological enbloc resection
Key secondary outcomes	The operation time and maintenance of mucosal elevation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	0.13% hyaluronic acid
Interventions/Control_2	normal saline
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	Patients who have agreement to our study and undergo endoscopic mucosal resecton using 0.13% hyaluronic acid for colorectal tumors with 5mm to 20mm in diameter
Key exclusion criteria	Patient who is not able to undergo colonic endoscopic mucosal resection by other organs disorder
Target sample size	200

Research contact person
Name of lead principal investigator	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Email

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, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Homepage URL
Email	naohisa@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	京都府立医科大学付属病院(京都府)

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2013 Year 04 Month 01 Day
Date of closure to data entry	2013 Year 08 Month 01 Day
Date trial data considered complete	2013 Year 08 Month 01 Day
Date analysis concluded	2013 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 04 Month 18 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=R000006472