The Randomized Non-inferiority Trial of 19G and 22G FNB Needles in Pancreatic Tumor (19GFNB)

JRCT ID: jRCT1042240023

Registered date:08/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 07/06/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Endoscopic ultrasound-guided fine needle biopsy

Outcome(s)

• Primary Outcome: Technical success rate

Secondary Outcome

Diagnostic accuracy
Rate of adverse events
Number of passes
Length of macroscopic visible core
Pathological score
Rate of patients with passed or qualified from the reports of F1CDx
Rate of patients with passed from the reports of F1CDx

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients suspected of pancreatic cancer based on image findings, determined to be either unresectable or borderline resectable.
(2) Patients undergoing tissue sampling through EUS-FNB.

Exclude criteria

(1) History of previous radiotherapy or chemotherapy for pancreatic cancer.
(2) Inability to temporarily discontinue anticoagulant therapy for EUS-FNB.

Related Information

• Primary Sponsor: Sato Junya