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Frappuccino Trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042240063
Enrollment
140
Registered
2024-07-26
Start date
2024-08-09
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 of 20 mm or less Pancreas

Interventions

Sponsors

Ishikawa Takuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cases with contrast-enhanced CT/MRI/EUS showing a solid lesion of 20 mm or less in the pancreas, with EUS-FNB histology scheduled and judged to be surgically resectable.However, unresectable lesions of 10 mm or less are also included. Patients must be at least 18 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

MeasureTime frame
Diagnostic capability for lesions of 20 mm or less.

Secondary

MeasureTime 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 performancemicroscope (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.

Contacts

Public ContactTakuya Ishikawa

Nagoya University Hospital

ishikawa.takuya.u9@f.mail.nagoya-u.ac.jp+81-52-744-2602

Outcome results

None listed

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