UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033156 |
|---|---|
| Receipt number | R000037810 |
| Scientific Title | Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2018/06/27 |
| Last modified on | 2021/06/03 10:09:36 |
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Basic information
Public title
Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Acronym
Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Scientific Title
Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Scientific Title:Acronym
Randomized study of two endo-knives for traction-assisted endoscopic submucosal dissection for early esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
early esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the performances of two endo-knives for traction-assisted endoscopic submucosal dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure time required for endoscopic 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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
esophageal ESD with Dual knife
Interventions/Control_2
esophageal ESD with IT knife nano
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) The patients scheduled for esophageal ESD
(2) with informed consent
Key exclusion criteria
(1) Previous surgery in esophagus
(2) Chemoradiotherapy for early esophageal squamous cell carcinoma
(3) Lesions located 10 mm within previous endoscopic resection scar
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Kitagawa |
Organization
Chiba Cancer Center
Division name
Endoscopy division
Zip code
260-8717
Address
666-2 Nitonacho, Chuo-ku, Chiba, Japan
TEL
043-264-5431
ykitagawa@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Kitagawa |
Organization
Chiba Cancer Center
Division name
Endoscopy division
Zip code
260-8717
Address
666-2 Nitonacho, Chuo-ku, Chiba, Japan
TEL
043-264-5431
Homepage URL
ykitagawa@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Chiba Cancer Center
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
Chiba Cancer Center
Address
666-2 Nitonacho, Chuo-ku, Chiba, Japan
Tel
043-264-5431
ykitagawa@chiba-cc.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
| 2018 | Year | 06 | Month | 27 | 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
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037810
