UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039176 |
|---|---|
| Receipt number | R000044515 |
| Scientific Title | A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2021/12/22 14:27:10 |
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Basic information
Public title
A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Acronym
A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Scientific Title
A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Scientific Title:Acronym
A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of cut-off value of stereomicroscopic visible white core length required for pathological diagnosis of pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity of pathological diagnosis using cut-off value
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
| Device,equipment |
Interventions/Control_1
Endoscopic ultrasound-guided biopsy using a 22-gauge biopsy needle
(If there is no stereomicroscopic visible white core exceeding 11mm, perform additional puncture up to 5 times.)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. providing written informed consent, and age =or >20
2. patients with pancreatic cancer suspected
3. unresectable or borderline resectable
Key exclusion criteria
1. patients with mental disorder
2. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
70
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 252-0374, Japan
TEL
042-778-8111
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 252-0374, Japan
TEL
042-778-8111
Homepage URL
m.wata@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
Kitasato University school of medicine, Institutional Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
Tel
042-778-8111
rinrib@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
Kitasto University Hospital(Kanagawa)，Isehara Kyodo Hospital(Kanagawa)，JCHO Sagamino Hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044515
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
