Pancreatic cancer (including suspected pancreatic cancer) Pancreas
Conditions
Interventions
Sponsors
Okuwaki Kosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final diagnostic accuracy of SecureFlex including up to two passes (1st and 2nd pass) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactMasafumi Watanabe
Kitasato University School of Medicine
Outcome results
None listed