Gastric Wall Tumor, GIST, Lymphadenopathies, Neuroendocrine Tumors, Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Neuroendocrine tumors, Lymphadenopathies, GIST, Gastrointestinal wall neoplasia
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.
Interventions
DEVICE25G needle
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
DEVICE22G needle
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of 22G and 25G needles | 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
| Measure | Time frame | Description |
|---|---|---|
| Ease of needle pass | 18 months | The subjective evaluation of the operator (easy or hard) |
| Needle malfunction | 18 months | Needles do not come out of the cover; kinking; needles do not puncture the tissue (presence or absence of malfunction, and registering of the specific malfunction) |
| Number of passes | 18 months | The total number of passes needed to obtain adequate material for each lesion (absolute number). |
| Number of crossovers | 18 months | The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures. |
| Major complications | 18 months | Bleeding (minor: visible at EUS but without clinical significance or less than 2 g/dl; major: dropping of more than 2 g/dl in Hb levels and clinically significant), perforation (presence/absence), infection (need for hospitalization). |
Countries
Italy
Contacts
Primary ContactSilvia Carrara, MD
Outcome results
None listed