Randomized comparison of three biopsy needles for diagnosing solid pancreatic masses
Official title: 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
Run by Mahidol University · NCT07032974 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok, Bangkok) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | June 24, 2025 |
| Trial ID | NCT07032974 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.