Randomized comparison of three biopsy needles for diagnosing solid pancreatic masses
Prospective Randomized Controlled Trial Comparing Accuracy Among Franseen, Forward-bevel Westcott, and Fork-tip Needle Design for EUS-guided Fine Needle Biopsy in Diagnosis of Solid Pancreatic Lesions
This test will see if three different endoscopic ultrasound biopsy needles (Franseen, forward-bevel/Westcott, and fork-tip) get better tissue samples for adults with solid pancreatic masses who need a diagnosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok, Bangkok) |
| Trial ID | NCT07032974 on ClinicalTrials.gov |
What this trial studies
In this randomized interventional trial, adults with solid pancreatic masses ≥1 cm will undergo EUS-guided tissue sampling with one of three FNB needle types (Franseen, forward-bevel/Westcott, or fork-tip). The primary focus is on diagnostic accuracy and sample adequacy, with secondary endpoints including number of needle passes, need for rapid on-site evaluation (ROSE), and procedure-related adverse events. Key exclusions include pregnancy, uncorrected coagulopathy, and surgically altered anatomy. All procedures and pathology evaluation are conducted at the Faculty of Medicine Siriraj Hospital, Mahidol University in Bangkok.
Who should consider this trial
Good fit: Adults over 18 with a solid pancreatic mass at least 1 cm in size who require tissue diagnosis and can give informed consent are ideal candidates.
Not a fit: Patients with cystic lesions, masses under 1 cm, pregnancy, uncorrected bleeding disorders, or surgically altered anatomy may not benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the best-performing needle could improve diagnostic accuracy, provide larger histologic samples, reduce the number of passes and need for on-site cytology, and speed treatment decisions.
How similar studies have performed: Previous studies have shown that FNB needle designs (including Franseen and fork-tip) often yield better tissue cores and histologic diagnostic rates than standard FNA, but direct randomized comparisons among these three specific needles are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Solid pancreatic mass greater than 1 cm in size who required tissue diagnosis Exclusion Criteria: * Pregnancy * Uncorrected coagulopathy * Surgically altered anatomy * Unable to complete informed consent
Where this trial is running
Bangkok, Bangkok
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Varayu Prachayakul, MD — Siriraj Hospital
- Study coordinator: Ronnakorn Kongsakon, MD
- Email: ronnagorn@gmail.com
- Phone: +66655979522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.