UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040582 |
|---|---|
| Receipt number | R000046312 |
| Scientific Title | A randomized controlled trial about the efficacy of colorectal ESD using a scissors-type knife with traction device for early colorectal neoplasms |
| Date of disclosure of the study information | 2020/05/29 |
| Last modified on | 2023/12/01 09:27:45 |
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Basic information
Public title
A randomized controlled trial about the efficacy of colorectal ESD using a scissors-type knife with traction device for early colorectal neoplasms
Acronym
RCT about the efficacy of colorectal ESD using a scissors-type knife with traction device
Scientific Title
A randomized controlled trial about the efficacy of colorectal ESD using a scissors-type knife with traction device for early colorectal neoplasms
Scientific Title:Acronym
RCT about the efficacy of colorectal ESD using a scissors-type knife with traction device
Region
| Japan |
Condition
Condition
Early colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To comparare about efficacy and safety of ESD using a scissors-type knife with traction device to without traction device for early colorectal neoplasms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the resected specimen area to the procedure time
Key secondary outcomes
Resection Time
En bloc resection rate
Complete resection rate
Curative resection rate
Complication rate
One-year residual recurrence rate
Incidence of damage to resected specimens due to traction devices
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A: C (Conventional)-ESD
Interventions/Control_2
Group B: T (Traction)-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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Lesions for which en bloc resection with snare EMR isdifficult to apply and tumor size is 20 to 50 mm.
(2) Aged 20 to 90 years old.
(3) PS (ECOG) performance status of 0,1or2.
(4) Without regard to gender.
(5) Patients taking one antithrombotic drug.
(6) Written informed consent
Key exclusion criteria
(1) preorerative endoscopic diagnosis of tumor depth is cT1b(SM2).
(2) The morphology of tumor is protruded.
(3) Lesions of local recurrence after endoscopic resection.
(4) Familial adenomatous polyposis and Inflamatory bowel disease.
(5) Patients taking more than two kinds of antithrombotic drugs.
(6) Patients with thrombocytopenia and/or bleeding tendency.
(7) Women during pregnancy.
(8) Patients enrolled in this study.
(9) Unsuitable patient for clinical trial judged by clinicians.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Kuwai |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Gastroenterology
Zip code
737-0023
Address
3-1 Aoyama-cho, Kure, Japan
TEL
+81-823-22-3111
kuwai.toshio.ur@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yuzuru |
| Middle name | |
| Last name | Tamaru |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Gastroenterology
Zip code
737-0023
Address
3-1 Aoyama-cho, Kure, Japan
TEL
+81-823-22-3111
Homepage URL
tamaru.yuzuru.vh@mail.hosp.go.jp
Sponsor or person
Institute
Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Address
3-1 Aoyama-cho, Kure, Japan
Tel
+81-823-22-3111
tamaru.yuzuru.vh@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
| 2020 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | 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 | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046312
