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

Macroscopic on Cite Evaluation of EUS-FNA Specimen of Gastrointestinal Tumours With Everyday Needle (22g EUS FNA Needle)

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.

Study Overview

• Status: Recruiting
• Conditions: GI Cancer
• Intervention / Treatment: Procedure: Endosonographic fine needle aspiration biopsy

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli
    • Izmit, Kocaeli, Turkey, 41001
      • Recruiting
      • Kocaeli University Medical Faculty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biopsy Arm; All patients who underwent EUS Guided biopsy	Procedure: Endosonographic fine needle aspiration biopsy; An endoscopic ultrasound device will be inserted to the stomach and biopsy will performed with a needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of a macroscopically visible fragments in the 22g EUS-FNA needle specimens with final histologic diagnosis	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.	1-2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2021
• Primary Completion (Anticipated): March 15, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MOSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared at Mendeley data sharing platform freely and publicly
• IPD Sharing Time Frame: 1 month after the study compilation
• IPD Sharing Access Criteria: publicly
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No