The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle

The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle - The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029612

Enrollment

100

Registered

2017-10-18

Start date

2017-08-31

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

Lesions with Indication for EUS-FNA

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age =or >20 (2) Requirement of EUS-FNA of a solid lesion (3) Use of the 25-gauge Franseen needle (4) Providing written informed consent

Exclusion criteria

Exclusion criteria: (1) Cystic lesion (2) PT-INR =or >1.5 (3) Platelate count < 50000/m3 (4) ASA =or >3 (5) ECOG-PS=4 (6) Pregnancy (7) Unsuitable for inclusion at the discretion of the physician.

Design outcomes

Primary

Measure	Time frame
The tissue acquisition rate in the initial puncture	—

Secondary

Measure	Time frame
(1) Quality of a tissue sample (2) Diagnostic accuracy Diagnostic accuracy, sensitivity, specificity, PPV, NPV in (3) pathological and (4) cytological malignancy or benignancy (5) Success rate of puncture (6) Adverse event rate in EUS-FNA	—

Countries

Japan

Contacts

Public ContactRyo Sugiura

Hokkaido University Faculty of Medicine and Graduate School of Medicine Department of Gastroenterology and Hepatology

rsugiura-hok@umin.ac.jp011-716-1161

Outcome results