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

Study Overview
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Brief Summary
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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.

Official Title
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Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial

Conditions
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Endoscopic Ultrasound, Fine-needle Aspiration

Intervention / Treatment
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* Procedure: Endoscopic ultrasound-guided fine-needle biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WET-SUCTION<br>The stylet will be removed and the needle will be pre-flushed with 1-2mL of saline. The lesion will then be punctured, and suction will be applied using a 10-mL pre-vacuum syringe. The sample collected will be pushed into a formalin vial with saline. | Procedure: Endoscopic ultrasound-guided fine-needle biopsy<br>* Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)<br>|
| Active Comparator: SLOW-PULL<br>After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm. The sample will be pushed into formalin using the stylet. | Procedure: Endoscopic ultrasound-guided fine-needle biopsy<br>* Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Cytological specimen (disaggregated cells representative of the target lesion not allowing for tissue architectural assessment) Histologic microfragments (sample adequate for histological evaluation, namely an architecturally intact piece of tissue but without a core) Histologic core (defined as an architecturally intact piece of tissue measuring at least 550 μ) | 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 High blood contamination (>50% of the surface) Moderate blood contamination (25-50% of the surface) Low blood contamination (<25% of the surface) | 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). | 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 | 6 months |