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

Not Applicable

Terminated

Conditions: Solid Tumor

Interventions: Procedure: Endoscopic ultrasound guided fine needle biopsy

Registration Number: NCT03264092

Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

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

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 55

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow pull	Endoscopic ultrasound guided fine needle biopsy	This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
Wet suction	Endoscopic ultrasound guided fine needle biopsy	This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique
Dry suction	Endoscopic ultrasound guided fine needle biopsy	This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique

Primary Outcome Measures

Name	Time	Method
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score	2 hours	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

Secondary Outcome Measures

Name	Time	Method
Blood Contamination Score of Each Specimen Obtained	2 hours	This is based on the following scale 1. Blood present 2. Blood clots present
Number of Participants Stratified Per the Number of Diagnostic Passes Required	2 hours	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.