The 22G Trident Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy

Launched by CHANGHAI HOSPITAL · Jun 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special needle called the 22G Trident needle, used during a procedure called an endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). This procedure helps doctors take small tissue samples from solid lumps in the pancreas to better understand what they are. The study will compare three different ways of using the needle to see which method provides the best quality tissue samples, with fewer blood contamination and more accurate results.

People who might be eligible for this study are adults between 18 and 80 years old who have a solid lump in their pancreas, larger than 1 centimeter, found through imaging tests like CT, MRI, or ultrasound, and need this biopsy for diagnosis. Participants will need to agree to join the study by signing a consent form. If eligible and enrolled, patients can expect to undergo the biopsy using the special needle with one of the three techniques being tested. The goal is to find the safest and most effective way to get tissue samples, which can help doctors diagnose pancreatic conditions more accurately. Some people won’t be able to join, such as those with certain heart or bleeding problems, pregnant women, or those who have already had a diagnosis from another biopsy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
• • 1. 18-80 years old (inclusive), male and female;
• • 2. patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
• • 3. written informed consent was obtained.
• Exclusion Criteria:
• • (Before the trial, participants could not be enrolled if they met any of the following requirements)
• • 1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
• • 2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
• • 3. confirmed pregnancy or possible pregnancy;
• • 4. pathological diagnosis has been obtained by other methods;
• • 5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.
• • 6. other situations where EUS-FNB could not be performed.