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

GI Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774679
• Other study ID #: MOSE
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2021
• Est. completion date: March 30, 2021

Study information

• Verified date: February 2021
• Source: Kocaeli University
• Contact: Hasan Yilmaz
• Phone: +905058774821
• Email: gyrusus[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. In 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

Related Conditions & MeSH terms

• GI Cancer

Intervention

Procedure:
• Endosonographic fine needle aspiration biopsy
An endoscopic ultrasound device will be inserted to the stomach and biopsy will performed with a needle

Locations

Country	Name	City	State
Turkey	Kocaeli University Medical Faculty Hospital	Izmit	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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