A prospective, randomized, non-comparative trial to explore the optimal methods of EUS-FNB for multiple-gene panel test

JRCT ID: jRCTs042210083

Registered date:12/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 11/11/2021
• Target sample size: 75
• Study type: Interventional
• Intervention(s): endoscopic ultrasound-guided fine needle biopsy

Outcome(s)

• Primary Outcome: Percentage of candidate samples for NGS

Secondary Outcome

Tumor area on a slide
Accuracy rate of EUS-FNB
Success rate of predetermined number of needle passes
Rate of successful of one needle pass
The number of needle passes
Procedure time
Adverse events during EUS-FNB
Post-procedure adverse events
Rate of passed or qualified report in patients who undergo F1CDx
Rate of passed report in patients who undergo F1CDx
Tumor area on a slide in patients who undergo F1CDx

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1)Patient with suspected pancreatic malignant tumor
Patient with no indication of radical resection
2)Patient <=80 years
3)Patient scheduled to have a genetic panel test using tumor tissue
4)Patient with performance status <=1 according to the ECOG standard.
5)Patient with no severe disorders in major organs
6)Written informed consent

Exclude criteria

1) Patient with history of radiation therapy or chemotherapy for pancreatic cancer.
2) Patient with the regular use of antithrombotic drugs that cannot be suspended during EUS-FNB
3) Patient with mental disorder
4) Inappropriate patient for the study

Related Information

• Primary Sponsor: Sato Junya
• Source(s) of Monetary Support: MEDICO'S HIRATA INC.