UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054748 |
|---|---|
| Receipt number | R000062250 |
| Scientific Title | Multicenter prospective study to validate the optimal number of punctures based on the results by stereomicroscopic on-site evaluation in EUS-TA for upper gastrointestinal subepithelial lesions. |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/08/10 12:59:02 |
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Basic information
Public title
Multicenter prospective study to validate the optimal number of punctures based on the results by stereomicroscopic on-site evaluation in EUS-TA for upper gastrointestinal subepithelial lesions.
Acronym
Multicenter prospective study to validate the optimal number of punctures based on the results by stereomicroscopic on-site evaluation in EUS-TA for upper gastrointestinal subepithelial lesions.
Scientific Title
Multicenter prospective study to validate the optimal number of punctures based on the results by stereomicroscopic on-site evaluation in EUS-TA for upper gastrointestinal subepithelial lesions.
Scientific Title:Acronym
Multicenter prospective study to validate the optimal number of punctures based on the results by stereomicroscopic on-site evaluation in EUS-TA for upper gastrointestinal subepithelial lesions.
Region
| Japan |
Condition
Condition
Upper gastrointestinal subepithelial lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the diagnostic sensitivity in EUS-TA for upper gastrointestinal subepithelial lesions when the puncture finished based on stereomicroscopic on-site evaluation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic sensitivity when puncture finished based on results by SOSE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Perform EUS-TA with 22gauge biopsy needle and finish the puncture based on results by SOSE
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Upper gastrointestinal subepithelial lesions diameter =or >20mm(detected by EUS or CT)
2. Providing written informed consent, and age =or >18
3. Patient required EUS-TA for pathological diagnosis
Key exclusion criteria
1. bleeding disorders
2. severe mental disorders
3. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami-ku Sagamihara Kanagawa, Japan
TEL
81-42-778-8111
kokuwaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami-ku Sagamihara Kanagawa, Japan
TEL
81-42-778-8111
Homepage URL
m.wata@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Institutional Ethics Committee of Kitasato University
Address
1-15-1 Kitasato Minami-ku Sagamihara Kanagawa, 252-0374 Japan
Tel
81-42-778-7756
rinri@med.kitasato-u.ac.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
Kitasato University Hospital
JCHO Sagamino Hospital
Kitasato University Medical Center
Isehara kyodo Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062250
