Macroscopic on Cite Evaluation of EUS-FNA Specimen With 22 G Needle

Kocaeli University

Status: Unknown

Conditions: GI Cancer

Treatments: Procedure: Endosonographic fine needle aspiration biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04774679

MOSE

Details and patient eligibility

About

In order for the diagnosis of digestive system tumors and their appropriate treatment afterward, the type of these tumors should be determined by the pathologist. Pathology doctors need sufficient tissue (a small part of the organ thought to be diseased) to make a diagnosis. Tissue samples were taken from the patients by biopsy procedure. It is examined with microscopes by performing various staining and occasionally it is reported that sufficient tissue cannot be provided to make a diagnosis. In this case, patients may be subjected to repeated biopsy procedures. The aim of this study is to investigate whether the biopsy material obtained by endoscopic ultrasonography (EUS) is sufficient for the diagnosis of the pathology physician with the naked eye. Researchers will try to determine to what extent the physician performing the biopsy procedure can predict whether the tissue he has obtained is sufficient for the pathologist. In this way, researchers think that fewer biopsy repetitions will be needed in the future.

Full description

This study was designed to improve the acquisition of sufficient tissue (EUS-FNA) with endosonography-assisted fine needle aspiration biopsy, which has been approved and used worldwide for the diagnosis of digestive system diseases. The procedure to be applied in the study is to determine the visible tissue fragments in the sample to be taken after the standard EUS-FNA procedure and to compare it with the diagnosis made by the pathologist. Patients with a tumor detected in the digestive system and referred to the investigation unit for tissue diagnosis will be included in this study. The data obtained in the study will be collected prospectively and will be analyzed retrospectively.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. İn the age range of 18-80 years old
2. Tumour detected withcross-sectional imagined technics in the digestive system

Exclusion criteria

1. Refuse to give written informed consent
2. Established bleeding disorder
3. INR>1.5IU plaelet count <100000/dL

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Biopsy Arm

Experimental group

Description:

All patients who underwent EUS Guided biopsy

Treatment:

Procedure: Endosonographic fine needle aspiration biopsy