Comparison Between 25-gauge and 22-gauge Franseen Needles with Taper Point Stylet for Endoscopic Ultrasound-guided Sampling of Small Solid Pancreatic Lesions of 20mm or less

Comparison Between 25-gauge and 22-gauge Franseen Needles with Taper Point Stylet for Endoscopic Ultrasound-guided Sampling of Small Solid Pancreatic Lesions of 20mm or less - Frappuccino Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053908

Enrollment

140

Registered

2024-05-01

Start date

2024-05-01

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

Cases in which contrast-enhanced CT/MRI/EUS shows a solid lesion of 20 mm or less in the pancreas and surgical resection is planned after histological diagnosis by EUS-FNB. However, unresectable cases of lesions smaller than 10 mm should also be included.

Interventions

Random allocation to 25-gauge needle and 22-gauge needle groups. Two punctures will be performed with the allocated needle, and the needle will be changed to the other needle if the rapid cytological

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cases in which contrast-enhanced CT/MRI/EUS shows a solid lesion of 20 mm or less in the pancreas and surgical resection is planned after histological diagnosis by EUS-FNB. However, unresectable lesions of 10 mm or less are also included. Patients must be at least 20 years old at the time of registration. Patients who have not used antithrombotic drugs within one week, or who are able to withdraw or use alternative therapies. Patients who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: Cases in which withdrawal or substitution of antithrombotic drugs is difficult. Patients with poorly controlled infections. Pregnancy or possible pregnancy and lactating women. Cases with severe mental disorders. Cases in which tissue samples are taken in anticipation of gene panel testing. Cases in which the principal investigator or research assistant deems the study to be unsuitable for safe conduct.

Design outcomes

Primary

Measure	Time frame
Diagnostic capability for lesions smaller than 20 mm.	—

Secondary

Measure	Time frame
Diagnostic performance for lesions less than 15 mm Diagnostic performance for lesions larger than 15 mm and smaller than 20 mm Diagnostic performance for small lesions of 10 mm or less. Diagnostic performance by lesion site. The specimen volume is assessed using a high performance microscope (BZ-X800). The proportion of 22-gauge to 25-gauge or 25-gauge to 22-gauge needles changed during the examination and whether this adds to the diagnostic performance. Rate of adverse events.	—

Measure

Time frame

Diagnostic performance for lesions less than 15 mm Diagnostic performance for lesions larger than 15 mm and smaller than 20 mm Diagnostic performance for small lesions of 10 mm or less. Diagnostic performance by lesion site. The specimen volume is assessed using a high performance microscope (BZ-X800). The proportion of 22-gauge to 25-gauge or 25-gauge to 22-gauge needles changed during the examination and whether this adds to the diagnostic performance. Rate of adverse events.

—

Countries

Japan

Contacts

Public ContactTakuya Ishikawa

Nagoya University Hospital Department of Gastroenterology and Hepatology

ishitaku@med.nagoya-u.ac.jp+81527442602

Outcome results

None listed

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