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Search / Trial NCT07023549

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

Launched by CHANGHAI HOSPITAL · Jun 15, 2025

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

22 G Franseen Needle Solid Pancreatic Lesion Aspiration Technique Endoscopic Ultrasound Guided Fine Needle Biopsy

ClinConnect Summary

This clinical trial is studying a special needle called the 22G Franseen needle, which is used to take small tissue samples from solid lumps in the pancreas during a procedure called an endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). The study wants to find out which suction method—dry-suction, wet-suction, or slow-pull—works best to get enough good-quality tissue for accurate diagnosis while minimizing blood contamination.

Adults between 18 and 80 years old who have a solid pancreatic lump larger than 1 cm found on scans like CT or MRI, and who need this biopsy for diagnosis, may be eligible. People with certain health problems that make the procedure unsafe (like serious heart or bleeding issues), pregnant women, or those who have already had a biopsy diagnosis are not eligible. If you join, you would undergo the biopsy procedure using the needle with one of the suction techniques, and the doctors will compare how well each method works. This study is not yet recruiting participants but aims to help improve diagnosis of pancreatic diseases in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • (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:
  • 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.

About Changhai Hospital

Changhai Hospital is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence, the hospital integrates cutting-edge medical technologies and a multidisciplinary approach to patient care. Changhai Hospital actively collaborates with research organizations and healthcare professionals to conduct rigorous clinical trials aimed at developing new treatments and improving patient outcomes. By prioritizing patient safety and ethical standards, the hospital plays a pivotal role in contributing to the advancement of medical knowledge and the enhancement of therapeutic options.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Zhao Shen Li, M.D

Principal Investigator

Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported