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Randomized trial in EUS-FNB for solid pancreatic lesions

Randomized Trial Comparing Franseen Needle Versus Trident Needle and Three-Point Needle in EUS-FNB for Solid Pancreatic Lesions - Fantathtic Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042220099
Enrollment
192
Registered
2022-11-25
Start date
2023-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid pancreatic lesions not less than 10 mm Pancreas

Interventions

Subjects will be randomly assigned to a conventional needle group or a new needle group for the needle used during EUS-FNB. Conventional needle group: 22G Franseen needle (Acquire TM) will be used. Ne

Sponsors

Ishikawa Takuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients with solid pancreatic lesions not less than 10 mm on CT or MRI which require histological diagnosis by EUS-FNB. (2)Patients over 20 years old at the time of enrollment. (3)Preservation of bone marrow function at the time of diagnosis. (4)Patients in which antithrombotic drugs are not used within one week or can be withdrawn or replaced. (5)Provision of written consent to participate in the study.

Exclusion criteria

Exclusion criteria: (1)Uncontrollable infection including active tuberculosis (2)Serious adverse events (3)Severe mental disorder (4)Judgement as being ineligible by the principal or subinvestigator.

Design outcomes

Primary

MeasureTime frame
Histological tissue collection rate

Secondary

MeasureTime frame
Histological tissue collection rate among new needles Histological diagnostic ability Puncture success rate at first shot Evaluation of the easiness of the puncture Adverse events Comparison of core tissue length and area

Contacts

Public ContactTakuya Ishikawa

Nagoya University Graduate School of Medicine

ishitaku@med.nagoya-u.ac.jp+81-52-744-2602

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026