UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030068 |
|---|---|
| Receipt number | R000034334 |
| Scientific Title | A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2023/05/29 08:21:53 |
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Basic information
Public title
A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size
Acronym
Device selection RCT in colorectal ESD (NANO STUDY)
Scientific Title
A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size
Scientific Title:Acronym
Device selection RCT in colorectal ESD (NANO STUDY)
Region
| Japan |
Condition
Condition
colorectal epitherial neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ITknife nano compared with Dual knife in colorectal ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Procedure time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dual knife group
Interventions/Control_2
ITknife nano group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who receive colorectal ESD
2) Colorectal epitherial neoplasms which are larger than 30 mm and smaller than 50 mm
3) Laterally spreading tumor (LST)
4) Written informed consent
Key exclusion criteria
1) cT1b(SM) cancer
2) non-LST lesions
3) Local recurrences/ Scar lesions
4) Easy bleeding disorder
5) Impossible to suspend anticoagulant or antiplatelet medications
6) Women during pregnancy
7) Inappropriate cases by investigators
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Kinichi |
| Middle name | |
| Last name | Hotta |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
0559895222
k.hotta@scchr.jp
Public contact
Name of contact person
| 1st name | Sayo |
| Middle name | |
| Last name | Ito |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
sa.ito@scchr.jp
Sponsor or person
Institute
Division of Endoscopy, Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Division of Endoscopy, Shizuoka Cancer Center
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
Certified Review Board
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel
0559895222
rinsho_office@schr.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
| 2017 | Year | 12 | 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
216
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
| 2017 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034334
