UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033073 |
|---|---|
| Receipt number | R000035142 |
| Scientific Title | Explorative study of EUS-elastography guided EUS-FNA for pancreatic neoplasms. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/12/24 16:18:38 |
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Basic information
Public title
Explorative study of EUS-elastography guided EUS-FNA for pancreatic neoplasms.
Acronym
Explorative study of EUS-elastography guided EUS-FNA for pancreatic neoplasms.
Scientific Title
Explorative study of EUS-elastography guided EUS-FNA for pancreatic neoplasms.
Scientific Title:Acronym
Explorative study of EUS-elastography guided EUS-FNA for pancreatic neoplasms.
Region
| Japan |
Condition
Condition
Pancreatic neoplasms in need histopathological diagnosis by EUS-FNA
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess and compare between the tissue elasticity and histological characteristics in the pancreatic neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the quality and quantity of histology by EUS-FNA.
Key secondary outcomes
The incidence of complications.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-FNA for pancreatic neoplasms.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients who need histopathological diagnosis for pancreatic neoplasms by EUS-FNA.
2) Patients who are from 20 to 85 years old.
3) Patients who provided written informed consent.
Key exclusion criteria
1)Patients who are not applicable to endoscopy.
2)Patients who judged as inappropriate by attendant doctor.
3)Patients who rejected participating in this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
466-8550
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Eizaburo |
| Middle name | |
| Last name | Ohno |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
466-8550
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
Homepage URL
eono@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate 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
Nagoya University
Address
65 tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2602
eono@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2018 | 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
Suspended
Date of protocol fixation
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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 | 20 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035142
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
