UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015762 |
|---|---|
| Receipt number | R000018343 |
| Scientific Title | A prospective randomized study of two endo-knives for endoscopic submucosal dissection of colorectal neoplasm. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2020/11/06 19:15:10 |
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Basic information
Public title
A prospective randomized study of two endo-knives for endoscopic submucosal dissection of colorectal neoplasm.
Acronym
Randomized study of device for endoscopic submucosal dissection.
Scientific Title
A prospective randomized study of two endo-knives for endoscopic submucosal dissection of colorectal neoplasm.
Scientific Title:Acronym
Randomized study of device for endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the efficiency of Mucosectom2 and SB knife for endoscopic submucosal dissection of colorectal neoplasm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure time required for submucosal dissection of Mucosectom2 and SB knife. (The time is combined process of injection under the mucosa, of circular mucosal incision and of dissection of submucosa.)
Key secondary outcomes
Total procedure time for the lesions had fibrosis.
Total procedure time for the lesions observed difficult.
En block resection rate.
Self-completion rates.
Number of hemostatic therapy.
Number of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Enrolled patients are enforced which groups of diveces Mucosectom2 group or SB knife Jr. at random.
Interventions/Control_2
Enrolled patients are enforced which groups of physician Y.S. or D.T. at random.
Interventions/Control_3
To allocate the size of the tumor can be stratified into 20-35mm and 36-50mm.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Lesion diagnosed colorectum tumor.
Lesion 20-50mm in diameter.
Cancer including submucosal invasion less than 1mm.
No lymph node or distant metastasis.
Not matter wether prior biopsy or not.
Key exclusion criteria
Patients had severe organ failure for performed ESD
Under 18 years.
Patients disagreement.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Harada |
Organization
Okayama University Graduate School of Medicine
Division name
Department of endoscopy
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7219
keita818@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuusaku Sugihara |
Organization
Okayama University Graduate School of Medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7219
Homepage URL
y.sugi117@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | 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
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
| 2014 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 26 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018343
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| Registered date | File name |
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