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

Texas Tech University Health Sciences Center, El Paso55 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Solid Tumor

Interventions

Endoscopic ultrasound guided fine needle biopsyPROCEDURE

Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ages between 18-80 years old 2. Sex: male or female 3. 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. 4. Patients who are able to give consent Exclusion Criteria: 1. Pregnant female 2. Coagulation disorders (platelets \< 50,000/mm3, INR \> 2) 3. Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure. 4. Cardiorespiratory dysfunction that precludes sedation. 5. Unable to provide informed consent

Locations (1)

Texas Tech university Health Sciences Center El Paso

El Paso, Texas, United States

Outcomes

Primary Outcomes

Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score

0: inadequate 1. limited cytological dx 2. adquate cytological dx 3. limited histological dx 4. adequate histological dx with low quality 5. adequate histological dx with high quality

Time frame: 2 hours

Secondary Outcomes

Blood Contamination Score of Each Specimen Obtained

This is based on the following scale 1. Blood present 2. Blood clots present

Time frame: 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.

Time frame: 2 hours

Data from ClinicalTrials.gov

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