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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039894
Receipt No. R000045332
Scientific Title Efficacy of complete clip closure of the mucosal defect after colorectal-ESD : A randomized controlled, multicenter trial (CCC trial)
Date of disclosure of the study information 2020/07/01
Last modified on 2020/03/21

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Basic information
Public title Efficacy of complete clip closure of the mucosal defect after colorectal-ESD
: A randomized controlled, multicenter trial (CCC trial)
Acronym CCC trial
Scientific Title Efficacy of complete clip closure of the mucosal defect after colorectal-ESD
: A randomized controlled, multicenter trial (CCC trial)
Scientific Title:Acronym CCC trial
Region
Japan

Condition
Condition colorectal neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of complete clip closure of the mucosal defect after colorectal-ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Delayed adverse event rates (Post-ESD coagulation syndrome, delayed bleeding, delayed perforation), intention to treat analysis
Key secondary outcomes Delayed adverse event rates, per protocol analysis
Success rate of complete clip closure
Duration of clip closure
Number of clips
Factors of incomplete closure
Factors of delayed adverse events
Hospital staying days

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 without clip closure after ESD
Interventions/Control_2 complete clip closure after ESD
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1.20mm-70mm colorectal lesions which will be treated by ESD
2.1 lesion per 1 patient
3.Adenoma or early cancer (pTis-pT1a)
4.Blood sample is within the specified values
5.Informed consent is obtained from the patient
Key exclusion criteria 1.Lesions extending to the ileocecal valve, appendiceal orifice, lower rectum, or diverticulum
2.cT1b or more
3.Metal allergy
4.Heparin bridging is needed
5.PS 3 or 4
6.Steroids or immunomodulators usage
7.Pregnant or breastfeeding
8.Patients who have been judged as in appropriate for this study
Target sample size 304

Research contact person
Name of lead principal investigator
1st name Yasushi
Middle name
Last name Yamasaki
Organization Okayama University Hospital
Division name Department of Gastroenterology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL +81-86-235-7219
Email yasshifive@yahoo.co.jp

Public contact
Name of contact person
1st name Yasushi
Middle name
Last name Yamasaki
Organization Okayama University Hospital
Division name Department of Gastroenterology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL +81-86-235-7219
Homepage URL
Email yasshifive@yahoo.co.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka Medical College
Osaka Red Cross Hospital
Takayama Red Cross Hospital
University of Miyazaki Hospital
Iwakuni Clinical Center
Okayama Clinical Center
Kurashiki Central Hospital
Tsuyama Chuo Hospital
Himeji Red Cross Hospital
Hiroshima Citizens Hospital
Fukuyama Medical Center
Mitoyo General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Hospital
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
Tel +86-235-7219
Email yasshifive@yahoo.co.jp

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 岡山大学病院(岡山県)
大阪医科大学附属病院(大阪府)   
大阪赤十字病院(大阪府)      
高山赤十字病院(岐阜県)      
宮崎大学医学部附属病院(宮崎県)  
岩国医療センター(山口県)     
岡山医療センター(岡山県)     
倉敷中央病院(岡山県)       
津山中央病院(岡山県)       
姫路赤十字病院(兵庫県)      
広島市民病院(広島県)       
福山医療センター(広島県)     
三豊総合病院(香川県)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 21 Day
Last modified on
2020 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045332

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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