UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027638 |
|---|---|
| Receipt number | R000031663 |
| Scientific Title | Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2020/11/06 19:19:25 |
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Basic information
Public title
Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study
Acronym
Two Electrosurgical Mode for Colorectal ESD
Scientific Title
Two Electrosurgical Mode for Endoscopic Submucosal Dissection of Colorectal Superficial Neoplasms: A Prospective Randomised Study
Scientific Title:Acronym
Two Electrosurgical Mode for Colorectal ESD
Region
| Japan |
Condition
Condition
Colorectal Superficial Neoplasms:
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compared the performances of the Endo-cut I mode and Swift-coagulation mode
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
procedure time required for submucosal dissection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
performed ESD with Endo-cut I mode
Interventions/Control_2
performed ESD with Swift-coagulation mode
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
(a)tumour diagnosed with colonoscopy before ESD
(b)lesions of 20-50 mm in diameter
(c)colorectal intra-mucosal or minutes-invaded cancer
(d)no lymph node or distant metastasis
Key exclusion criteria
(a) non-correctable coagulopathy
(b) severe organ failure
(c) a comorbidity requiring continuous antithrombotic medication
Target sample size
128
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
Division of Endoscopy
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7219
keita818@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuusaku Sugihara |
Organization
Okayama University Graduate School of Medicine
Division name
general medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7219
Homepage URL
y.sugi117@gmail.com
Sponsor or person
Institute
Division of Endoscopy
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
| 2017 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 07 | 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
| 2017 | Year | 06 | Month | 05 | 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=R000031663
