Frappuccino Trial

JRCT ID: jRCT1042240063

Registered date:26/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid pancreatic lesions of 20 mm or less
• Date of first enrollment: 09/08/2024
• Target sample size: 140
• Study type: Interventional
• Intervention(s): 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 examination (ROSE) indicates that the specimen has not been collected, or if the endoscopist judges that the specimen is insufficient by gross examination (MOSE). However, changing the needle in such situations is also done in normal practice and the number of punctures will not be increased for this study.

Outcome(s)

• Primary Outcome: Diagnostic capability for lesions of 20 mm or less.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ishikawa Takuya