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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04774679
Enrollment
50
Registered
2021-03-01
Start date
2021-02-06
Completion date
2021-03-30
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GI Cancer

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.

Interventions

PROCEDUREEndosonographic fine needle aspiration biopsy

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

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of a macroscopically visible fragments in the 22g EUS-FNA needle specimens with final histologic diagnosis1-2 weeksMacroscopic 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

MeasureTime frameDescription
Area Under the size of the macroscopically visible core size versus histologic core size1-2 weeksMacroscopically visiable core size obtained via 22G EUS -FNA needle and pathologic size of cores will be compared by using

Countries

Turkey (Türkiye)

Contacts

Primary ContactHasan Yılmaz
gyrusus@yahoo.com+905058774821
Backup ContactAli Erkan Duman
dralierkanduman@hotmail.com+905335640607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026