Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions

Azienda Ospedaliera Universitaria Integrata Verona200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

200

Conditions

Endoscopic Ultrasound Fine-needle Aspiration

Interventions

Endoscopic ultrasound-guided fine-needle biopsyPROCEDURE

Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Azienda Ospedaliera Integrata Verona

Verona, Italy

Outcomes

Primary Outcomes

Histologic yield

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

Time frame: 6 months

Secondary Outcomes

Tissue integrity

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)

Time frame: 6 months

Blood contamination

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)

Time frame: 6 months

Tumor fraction

The rate of samples containing an adequate tumor fraction ≥20 percent (i.e., ≥ 20 percent tumor cells in a background of benign nucleated cells).

Time frame: 6 months

Diagnostic accuracy

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

Time frame: 6 months

Data from ClinicalTrials.gov

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