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

NCT04774679 | Unknown

• 1 other identifier: MOSE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

GI Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Area Under the size of the macroscopically visible core size versus histologic core size

  1-2 weeks

Study Arms (1)

Biopsy Arm

EXPERIMENTAL

All patients who underwent EUS Guided biopsy

Procedure: Endosonographic fine needle aspiration biopsy

Interventions

Endosonographic fine needle aspiration biopsy PROCEDURE

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

Biopsy Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• İn the age range of 18-80 years old
• Tumour detected withcross-sectional imagined technics in the digestive system

You may not qualify if:

• Refuse to give written informed consent
• Established bleeding disorder
• INR\>1.5IU plaelet count \<100000/dL

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Medical Faculty Hospital

İzmit, Kocaeli, 41001, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Hasan Yılmaz

CONTACT

+905058774821; gyrusus@yahoo.com

Ali Erkan Duman

CONTACT

+905335640607; dralierkanduman@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: March 1, 2021
• Study Start: February 6, 2021
• Primary Completion: March 15, 2021
• Study Completion: March 30, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: 1 month after the study compilation
• Access Criteria: publicly

Locations

TU (1)