UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060703 |
|---|---|
| Receipt number | R000069441 |
| Scientific Title | A multicenter prospective comparative study of 19G Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) needles for mediastinal and intraperitoneal lymphadenopathy |
| Date of disclosure of the study information | 2026/02/18 |
| Last modified on | 2026/02/18 17:05:33 |
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Basic information
Public title
A multicenter prospective comparative study of 19G Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) needles for mediastinal and intraperitoneal lymphadenopathy
Acronym
Prospective comparison of 19G FNA and FNB needles in the diagnosis of lymphoma
Scientific Title
A multicenter prospective comparative study of 19G Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) needles for mediastinal and intraperitoneal lymphadenopathy
Scientific Title:Acronym
Prospective comparison of 19G FNA and FNB needles in the diagnosis of lymphoma
Region
| Japan |
Condition
Condition
mediastinal or abdominal lymphadenopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic ability and safety of 19G FNA/FNB needles for mediastinal or intraperitoneal lymphadenopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of histopathological examination: Non-inferiority of 19G FNA needle to 19G FNB needle
Key secondary outcomes
Pathological cytological accuracy
Sensitivity of immunohistochemical staining in malignant lymphoma
Sensitivity of surface markers in malignant lymphoma
Sensitivity of chromosome testing in malignant lymphoma
Sensitivity of FISH in malignant lymphoma
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
19G FNA needle
Interventions/Control_2
19G FNB needle
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Cases with mediastinal or abdominal lymphadenopathy detected by CT or ultrasound imaging.
2. Cases with lymphadenopathy without a pathological diagnosis.
3. Patients aged 18 years or older.
4. Lymphadenopathy of 10mm or greater.
5. Patients not taking oral anticoagulants.
Key exclusion criteria
1. Cases in which a pathological diagnosis of lymph node swelling has already been made
2. Cases in which endoscopic examination is difficult
3. Cases in which consent to participate in this study cannot be obtained
4. Other cases in which this study is considered medically inappropriate
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunami General Hospital
Division name
Gastroenterology
Zip code
501-6062
Address
Dendai 185-1, Kasamatsu-cho, Hashima-gun, GIFU prefecture
TEL
058-388-0111
mkobdkl@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunami General Hospital
Division name
Gastroenterology
Zip code
501-6062
Address
Dendai 185-1, Kasamatsu-cho, Hashima-gun, GIFU prefecture
TEL
0583880111
Homepage URL
mkobdkl@yahoo.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Self-sourced
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
Gifu University Hospital
Address
1-1 Yanagido, Gifu City
Tel
0582306000
ueshin550621@gmail.com
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
| 2026 | Year | 02 | Month | 18 | 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
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069441
