UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039894 |
|---|---|
| Receipt number | 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 | 2022/03/23 11:46:31 |
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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
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
yasshifive@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 26 | Day |
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
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045332
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| Registered date | File name |
| Research case data | |
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