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JAPANESE
国立保健医療科学院
JRCT ID: jRCT1042240063

Registered date:26/07/2024

Frappuccino Trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSolid pancreatic lesions of 20 mm or less
Date of first enrollment09/08/2024
Target sample size140
Countries of recruitment
Study typeInterventional
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 OutcomeDiagnostic capability for lesions of 20 mm or less.
Secondary OutcomeDiagnostic 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 maximumNot applicable
GenderBoth
Include criteriaCases 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 criteriaCases 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

Contact

Public contact
Name Takuya Ishikawa
Address 65 Tsurumai-cho, Showa-ku, Nagoya Aichi Japan 466-8560
Telephone +81-52-744-2602
E-mail ishikawa.takuya.u9@f.mail.nagoya-u.ac.jp
Affiliation Nagoya University Hospital
Scientific contact
Name Takuya Ishikawa
Address 65 Tsurumai-cho, Showa-ku, Nagoya Aichi Japan 466-8560
Telephone +81-52-744-2602
E-mail ishikawa.takuya.u9@f.mail.nagoya-u.ac.jp
Affiliation Nagoya University Hospital