Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors.

Study Overview
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Brief Summary
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The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.

Detailed Description
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Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range of specimen adequacy when performing pancreatic biopsies with the standard fine needle aspiration (FNA) needles with this modality. There are several factors that affect the overall diagnostic yield of this procedure, such as endosonographer experience, presence of cytopathologist during the procedure, the needle diameter and the number of passes. In this study we will compare the yield of recently available fine biopsy needles (FNB) using three different techniques to obtain samples from solid lesions. The three techniques to be compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS). wall cells. In the suction technique the stylet of the needle can be left in place or removed before puncturing the lesion. Once the needle is inside the target, negative pressure is applied through a 10 or 20 cc syringe connected to the needle. The wet suction technique consists of flushing of the needle with 5 ml of saline solution to replace the column of air within the lumen of needle with saline solution before needle aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc syringe connected to the needle. In the slow pull technique, the stylet is left in place in the needle and is slightly retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is pushed completely into the needle to remove any contaminant cells and several back and forth movements are done while slowly withdrawing the stylet.

Official Title
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Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.

Conditions
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Solid Tumor

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: Ages between 18-80 years old Sex: male or female Patients who require EUS and tissue sampling of solid solid lesions (size >1 cm) anywhere in the following locations: lymph nodes, stomach, esophagus, colon, small intestine, pancreas, liver, spleen or kidney. Patients who are able to give consent Exclusion Criteria: Pregnant female Coagulation disorders (platelets < 50,000/mm3, INR > 2) Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure. Cardiorespiratory dysfunction that precludes sedation. Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wet suction<br>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique | Procedure: Endoscopic ultrasound guided fine needle biopsy<br>* Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance<br>|
| Experimental: Dry suction<br>This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique | Procedure: Endoscopic ultrasound guided fine needle biopsy<br>* Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance<br>|
| Experimental: Slow pull<br>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique | Procedure: Endoscopic ultrasound guided fine needle biopsy<br>* Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 0: inadequate limited cytological dx adquate cytological dx limited histological dx adequate histological dx with low quality adequate histological dx with high quality | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Contamination Score of Each Specimen Obtained | This is based on the following scale Blood present Blood clots present | 2 hours | 
| Number of Participants Stratified Per the Number of Diagnostic Passes Required | This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol. | 2 hours |