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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004719
Receipt No. R000005618
Scientific Title Multicenter study for the efficacy of hyaluronic acid in colonic endoscopic mucosal resection
Date of disclosure of the study information 2010/12/14
Last modified on 2018/09/05

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Basic information
Public title Multicenter study for the efficacy of hyaluronic acid in colonic endoscopic mucosal resection
Acronym The efficacy of hyaluronic acid in colonic EMR
Scientific Title Multicenter study for the efficacy of hyaluronic acid in colonic endoscopic mucosal resection
Scientific Title:Acronym 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 multicenter study is to evaluate the efficacy of 0.13% hyaluronic acid in endoscopic muscosal resection for colorectal tumors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The rate of endoscopic and histopathological enbloc resection
Key secondary outcomes Perforation rate
Post hemorrhagic rate
The efficacy of less experienced doctor

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
Medicine
Interventions/Control_1 0.13% hyaluronic acid
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have agreement to our study and undergo endoscopic mucosal resection using 0.13% hyaluronic acid for colorectal tumors with 5mm to 20mm in diameter
Key exclusion criteria Patients who is not able to undergo colonic endoscopic mucosal resection by other organ's disorder
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 綾部市立病院(京都府)、宇治武田病院(京都府)、亀岡市立病院(京都府)、学研都市病院(京都府)、京都第一赤十字病院(京都府)、社会保険京都病院(京都府)、市立奈良病院(奈良県)、市立福知山市民病院(京都府)、JR大阪鉄道病院(大阪府)、武田総合病院(京都府)、西陣病院(京都府)、与謝の海病院(京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 13 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=R000005618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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