A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- Istituto Clinico Humanitas
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Clinical performance of 22G and 25G needles
- Last Updated
- 11 years ago
Overview
Brief Summary
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.
The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.
Investigators
Michele Tedeschi
MD
Istituto Clinico Humanitas
Eligibility Criteria
Inclusion Criteria
- •endosonographic appearance of a solid lesions
- •age \>18 years
- •informed consent.
Exclusion Criteria
- •alteration of the coagulation (INR \>1.5, PLT \<50 x 103 /µL)
- •inability to express consent
Outcomes
Primary Outcomes
Clinical performance of 22G and 25G needles
Time Frame: 18 months
Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.
Secondary Outcomes
- Number of crossovers(18 months)
- Major complications(18 months)
- Needle malfunction(18 months)
- Ease of needle pass(18 months)
- Number of passes(18 months)