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

JRCT ID: jRCT1062210071

Registered date:19/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic mass
• Date of first enrollment: 04/02/2022
• Target sample size: 44
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Collection rate of adequate tissue sampling for Cancer Gene Panel Test

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with solid pancreatic mass planned for Cancer Gene Panel Testing using EUS-FNB samples

Exclude criteria

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

Related Information

• Primary Sponsor: Hironari Kato