NIPH Clinical Trials Search

Diagnostic performance of EUS-guided biopsy using the SecureFlex needle for pancreatic tumors

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Pancreatic cancer (including suspected pancreatic cancer)
Date of first enrollment	09/02/2026
Target sample size	34
Countries of recruitment
Study type	Interventional
Intervention(s)	In this study, EUS-FNA will be performed using only a 22-gauge SecureFlex needle under standard procedural techniques and established safety protocols.

Outcome(s)

Primary Outcome	Final diagnostic accuracy of SecureFlex including up to two passes (1st and 2nd pass)
Secondary Outcome	1. Diagnostic accuracy at the first pass 2. Incremental diagnostic yield 3. Achievement rate of the stereomicroscopically visible white core (SVWC) cutoff 4. Diagnostic accuracy according to SVWC cutoff status 5. EUS-FNA related adverse events

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Patients suspected of having pancreatic cancer based on imaging studies, who are deemed to require pathological confirmation to determine the treatment strategy. 2. Patients assessed by imaging as having borderline resectable or unresectable pancreatic cancer. 3. Patients who, within 14 days prior to enrollment, demonstrate adequate major organ function on physical examination and laboratory testing to tolerate sedation required for the procedure. 4. Patients aged 18 years or older who have provided written informed consent to participate in the study.
Exclude criteria	1. Patients considered to be at high risk of bleeding and deemed unsuitable for safe performance of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). 2. Patients suspected of having resectable pancreatic cancer. 3. Patients with surgically reconstructed gastrointestinal anatomy, except for Billroth I reconstruction. 4. Patients in whom a safe needle trajectory cannot be secured due to the presence of major vessels along the puncture route. 5. Pregnant patients or patients with a possibility of pregnancy. 6. Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigators for medical or safety-related reasons.