UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025293 |
|---|---|
| Receipt number | R000029071 |
| Scientific Title | Feasibility study of a new model Endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNAB) needles |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2023/06/21 10:00:04 |
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Basic information
Public title
Feasibility study of a new model Endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNAB) needles
Acronym
Nagoya univ. EUS-FNA needle study
Scientific Title
Feasibility study of a new model Endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNAB) needles
Scientific Title:Acronym
Nagoya univ. EUS-FNA needle study
Region
| Japan |
Condition
Condition
Surgically resected specimen of pancreatic tumor or Gastrointestinal subepithelial lesion(SEL).
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the performance and feasibility of newly designed EUS-FNAB needle for pancreatic tumor and GI SEL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the quality and quantity of histology as determined by total tissue area and tumor percentage in tissue by using newly designed EUS-FNAB needles.
Key secondary outcomes
To assess the resistance force in puncture to the tumor tissue
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
| Device,equipment |
Interventions/Control_1
Puncture into the surgically resected specimen
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)Patients who underwent surgical resection for gastrointestinal malignancy.
2)Resected specimen is suitable or appropriate for puncture.
3)Patients who provided written informed consent.
Key exclusion criteria
1)patients who rejected participating in this study
2)Patients judged as inappropriate by attendant doctor.
3)When serious damages expected by needle puncture.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
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 | |
| Middle name | |
| Last name | Eizaburo Ohno |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
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
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National institute of Advanced Industrial Science and Technology
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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029071
