UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061459 |
|---|---|
| Receipt number | R000070332 |
| Scientific Title | A Prospective Clinical Study on the Utility of EUS-guided Fine-Needle Aspiration for Right Hepatic Lobe Lesions |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/06 18:59:21 |
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Basic information
Public title
A Prospective Clinical Study on the Utility of EUS-guided Fine-Needle Aspiration for Right Hepatic Lobe Lesions
Acronym
Utility of EUS-FNA for Right Hepatic Lobe Lesions
Scientific Title
A Prospective Clinical Study on the Utility of EUS-guided Fine-Needle Aspiration for Right Hepatic Lobe Lesions
Scientific Title:Acronym
Utility of EUS-FNA for Right Hepatic Lobe Lesions
Region
| Japan |
Condition
Condition
Right Hepatic Lobe Lesions
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the diagnostic performance, technical success rate, and safety of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for right hepatic lobe lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy of EUS-FNA in each right hepatic segment (S5, S6, S7, and S8)
Key secondary outcomes
Visualization rate, puncture success rate, and adverse events of EUS-FNA in each right hepatic segment (S5, S6, S7, and S8)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-FNA
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adequate major organ function (bone marrow, cardiac, hepatic, pulmonary, and renal function) is preserved.
2) Patients with a performance status suitable for endoscopy: ECOG Performance Status 0, 1, or 2.
3) Patients expected to survive for at least 4 weeks.
4) Written informed consent has been obtained from the patient.
Key exclusion criteria
1) Patients with a history of surgical resection of the right hepatic lobe.
2) Patients at high risk of bleeding:
Platelet count < 50,000
PT-INR >= 1.5
APTT >= 1.5 times the upper limit of normal
3) Patients with gastrointestinal stenosis.
4) Patients with massive ascites in whom a safe puncture route cannot be secured.
5) Patients with active infection or uncontrolled cholangitis or sepsis.
6) Patients in whom the operator judges that lesion visualization or a safe puncture route cannot be achieved by EUS.
7) Patients deemed inappropriate for this study by the attending physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Okuno |
Organization
Aichi Cancer Center
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
Homepage URL
nokuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center
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
IRB, Aichi Cancer Center Hospital
Address
1-1, Kanokoden, Chikusa-ku, Nacoya, Aichi, Japan
Tel
0527626111
irb@aichi-cc.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-0-661
Org. issuing International ID_1
Aichi Cancer Center
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 | 05 | Month | 11 | 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
| 2026 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070332
