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

NCT ID: NCT04774679

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-06
• Study Completion Date: 2021-03-30

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.

Conditions

GI Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Biopsy Arm

All patients who underwent EUS Guided biopsy

Group Type: EXPERIMENTAL

Endosonographic fine needle aspiration biopsy

Intervention Type: PROCEDURE

An endoscopic ultrasound device will be inserted to the stomach and biopsy will performed with a needle

Interventions

Endosonographic fine needle aspiration biopsy

An endoscopic ultrasound device will be inserted to the stomach and biopsy will performed with a needle

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Hasan Yılmaz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University Medical Faculty Hospital

İzmit, Kocaeli, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hasan Yılmaz

Role: CONTACT

gyrusus@yahoo.com

+905058774821

Ali Erkan Duman

Role: CONTACT

dralierkanduman@hotmail.com

+905335640607

Facility Contacts

Hasan Yılmaz, MD

Role: primary

gyrusus@yahoo.com

+905058774821

Other Identifiers

MOSE

Identifier Type: -

Identifier Source: org_study_id