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 | 2026/08/19 10:55:41 |
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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
The primary outcome was the incidence of delayed adverse events within 28 days after colorectal ESD, defined as a composite of PECS, delayed bleeding, and delayed perforation in the FAS.
Key secondary outcomes
(1) Incidence of clinically significant delayed adverse events in the FAS, consisting of severe delayed bleeding and severe delayed perforation
(2) Incidence of PECS in the FAS
(3) Incidence of delayed bleeding in the FAS
(4) Incidence of delayed perforation in the FAS
(5) Same outcomes in the PPS
(6) Predictive factors of delayed adverse events
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
(i) lesion size 20-70 mm
(ii) only the target lesion scheduled for endoscopic resection during the procedure
(iii) lesions diagnosed preoperatively as cT1a or shallower
(iv) laboratory findings within 56 days before enrollment showing white blood cell count <10000/mm3, hemoglobin >8.0 g/dL, platelet count >100000/mm3, aspartate aminotransferase and alanine aminotransferase <100 U/L, serum creatinine <2.0 mg/dL, and C-reactive protein <0.5 mg/dL
(v) age 20-85 years
(vi) provision of written informed consent
Key exclusion criteria
(i) lesions diagnosed as cT1b or deeper
(ii) lesions involving the ileocecal valve, appendiceal orifice, dentate line, or diverticulum
(iii) history of metal allergy
(iv) continuation of more than 2 antithrombotic agents during ESD or requirement for heparin bridging
(v) inflammatory bowel disease
(vi) Eastern Cooperative Oncology Group performance status >2
(vii) use of corticosteroids or immunomodulatory agents
(viii) pregnancy
(ix) patients deemed unsuitable for study participation by the investigator.
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
NHO Iwakuni Clinical Center
Okayama Saiseikai General Hospital
University of Miyazaki Hospital
Tsuyama Chuo Hospital
Osaka Red Cross Hospital
Kansai Medical University Medical Center
NHO Fukuyama Medical Center
Japanese Red Cross Society Himeji Hospital
Japanese Red Cross Gifu Hospital
Osaka Medical and Pharmaceutical University
Kurashiki Central Hospital
Okayama Rosai Hospital
NHO Okayama Medical Center
Hiroshima City Hiroshima Citizens Hospital
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
Okayama University Hospital
NHO Iwakuni Clinical Center
Okayama Saiseikai General Hospital
University of Miyazaki Hospital
Tsuyama Chuo Hospital
Osaka Red Cross Hospital
Kansai Medical University Medical Center
NHO Fukuyama Medical Center
Japanese Red Cross Society Himeji Hospital
Japanese Red Cross Gifu Hospital
Osaka Medical and Pharmaceutical University
Kurashiki Central Hospital
Okayama Rosai Hospital
NHO Okayama Medical Center
Hiroshima City Hiroshima Citizens Hospital
Mitoyo General Hospital
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
307
Results
Delayed adverse events after colorectal ESD were significantly less frequent with CCC than with WC (12.7% vs 22.3%, P=0.032). Delayed bleeding was also significantly reduced with CCC (2.0% vs 7.4%, P=0.041). PECS and delayed perforation did not differ significantly. Antithrombotic use was independently associated with delayed adverse events and delayed bleeding.
Results date posted
| 2026 | Year | 08 | Month | 19 | Day |
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
No longer 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
| 2025 | 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
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045332
