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

Not Applicable

• Conditions: GI Cancer
• Interventions: Procedure: Endosonographic fine needle aspiration biopsy

• Registration Number: NCT04774679
• Lead Sponsor: Kocaeli University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-06
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsy Arm	Endosonographic fine needle aspiration biopsy	All patients who underwent EUS Guided biopsy

Primary Outcome Measures

Name	Time	Method
Correlation of a macroscopically visible fragments in the 22g EUS-FNA needle specimens with final histologic diagnosis	1-2 weeks	Macroscopic appearance of the tissue fragments obtained by 22G EUS-FNA needle will be assessed by the endoscopist immediately in the endoscopy room. Endoscopits will decide the tissue acquisition is adequate. The diagnostic yield of the specimens determined by a pathologist will be compared to the endoscopist's first decision according to the macroscopic appearance.

Secondary Outcome Measures

Name	Time	Method
Area Under the size of the macroscopically visible core size versus histologic core size	1-2 weeks	Macroscopically visiable core size obtained via 22G EUS -FNA needle and pathologic size of cores will be compared by using

Trial Locations

Locations (1)

Kocaeli University Medical Faculty Hospital; 🇹🇷 Izmit, Kocaeli, Turkey