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

UMIN ID: UMIN000053908

Registered date:01/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: 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.
• Date of first enrollment: 2024/05/01
• Target sample size: 140
• Countries of recruitment: Japan
• 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.
As the site of puncture (pancreatic head/uncinate and pancreatic body/tail) is considered to be a factor that may influence the tissue collection rate, the pancreatic head/uncinate and pancreatic body/tail are allocated to two groups, the 25-gauge needle group and the 22-gauge needle group, using the head/uncinate and body/tail as allocation factors.

Outcome(s)

• Primary Outcome: Diagnostic capability for lesions smaller than 20 mm.
• 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 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• 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: Nagoya University
• Source(s) of Monetary Support: self funding