臨床研究等提出・公開システム

A prospective randomized controlled trial of comparing 22 and 19G needles for tissue sampling with EUS-FNB for Cancer Gene Panel Test in solid pancreatic masses

Comparing 22 and 19G needles with EUS-FNB sampling for Cancer Gene Panel Test

Matsumoto Kazuyuki

Okayama University Hospital

2-5-1, shikata-cho, kita-ku, okayama city, okayama

matsumoto.k@okayama-u.ac.jp

Kazuyuki Matsumoto

Okayama University Hospital

2-5-1, shikata-cho, kita-ku, okayama city, okayama

+81-86-235-7219

matsumoto.k@okayama-u.ac.jp

Complete

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

diagnostic purpose

Patients with solid pancreatic mass planned for Cancer Gene Panel Testing using EUS-FNB samples

Performance status 3-4
Bleeding tendency or platelet count less than 50000/mm2
Taking two or more anti-thrombotic drugs
Difficult to perform EUS-FNB with safe due to interval vessels
Pregnant
Patients who could not obtain suitable informed consent
Patients judged by the reseach doctors as inappropriate subjects

Both

Pancreatic mass

RCT study (1:1 ratio)
1 First EUS-FNB using 22G needle, second EUS-FNB using 19G needle
2 First EUS-FNB using 19G needle, second EUS-FNB using 22G needle

Collection rate of adequate tissue sampling for Cancer Gene Panel Test

Tumor cell ratio
Tissue section surface area
Estimated amount of nucleic acid
Core tissue length
Histology score
Technical success
Adverse event
Success rate of Cancer Gene Panel Test
When there was a poorly enhanced area in tumor with CE-EUS, the above pathological evaluation will be performed using tissue samples obtained from poorly enhanced area

No

none