Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules

February 16, 2021 updated by: Ahmed Aouf, Kafrelsheikh University

Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules, A Prospective Study

The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher.

Exclusion Criteria:

  • Patients with a history of hemodynamic instability or inadequate coagulation profile were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FNB
Procedure: FNB
Fine needle aspiration from the nodules
Procedure: Core biopsy
Core biopsy from thyroid nodules
Active Comparator: Core biopsy
Procedure: FNB
Fine needle aspiration from the nodules
Procedure: Core biopsy
Core biopsy from thyroid nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of samples in FNB and CNB matching the final pathology
Time Frame: 7 days
Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Collaborators

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124569124577

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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