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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2020-10-01

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.

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Wet suction

This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique

Group Type EXPERIMENTAL

Endoscopic ultrasound guided fine needle biopsy

Intervention Type PROCEDURE

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

Dry suction

This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique

Group Type EXPERIMENTAL

Endoscopic ultrasound guided fine needle biopsy

Intervention Type PROCEDURE

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

Slow pull

This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique

Group Type EXPERIMENTAL

Endoscopic ultrasound guided fine needle biopsy

Intervention Type PROCEDURE

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

Interventions

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Endoscopic ultrasound guided fine needle biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No