Endoscopic Ultrasound, Fine-needle Aspiration
Conditions
Brief summary
A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles.
Interventions
PROCEDUREEndoscopic ultrasound-guided fine-needle biopsy
Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid pancreatic lesions 3 1cm * Peri-GI tract lymph nodes 3 1cm * Peri-GI tract masses * Lesions of the GI wall * Signed informed consent
Exclusion criteria
* Pancreatic cystic lesions (more than 50% of the volume) * Diameter of lesion ≤ 1 cm * Lesion not seen at EUS * Pregnancy * Coagulopathy (platelet count \<50.000/mm3 and/or international normalized ratio \>1.5); * Severe cardiorespiratory dysfunction precluding endoscopy; * Failure to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histologic yield | 6 months | The rate of samples containing a tissue core (yes/no) for histological evaluation, defined as an intact piece of tissue of at least 550 μ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue integrity | 6 months | Tissue integrity will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: No cells/tissue 1. Cytological specimen (disaggregated cells representative of the target lesion not allowing for tissue architectural assessment) 2. Histologic microfragments (sample adequate for histological evaluation, namely an architecturally intact piece of tissue but without a core) 3. Histologic core (defined as an architecturally intact piece of tissue measuring at least 550 μ) |
| Blood contamination | 6 months | Blood contamination will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: Only blood 1. High blood contamination (\>50% of the surface) 2. Moderate blood contamination (25-50% of the surface) 3. Low blood contamination (\<25% of the surface) |
| Tumor fraction | 6 months | The rate of samples containing an adequate tumor fraction ≥20 percent (i.e., ≥ 20 percent tumor cells in a background of benign nucleated cells). |
| Diagnostic accuracy | 6 months | Diagnostic accuracy (defined as the ratio between the sum of true positive and true negative values divided by the number of lesions) will be calculated for each study arm |
Countries
Italy
Outcome results
None listed