Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland

April 3, 2022 updated by: Paker Miki, HaEmek Medical Center, Israel

Ultrasound Guided Fine Needle Aspiration of Parathyroid Gland as a Pre Operative Localization Tool to Identify Pathological Parathyroid

Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The investigators would like to show that one exam that includes ultrasound and fine needle aspiration of the parathyroid gland for parathyroid hormone level is as accurate as the traditional method.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A prospective, open label, single arm trial that includes participants that suffer hypercalcemia due to primary hyperparathyroidism and are candidates for parathyroidectomy.

participants visit the investigator's head and neck clinic. the investigator confirms that the participant has an indication for parathyroidectomy according to the official criteria. Later on, the investigator looks at the localization tests that have already been done (neck ultrasound and MIBI [methoxyisobutyllisonitrile] scan) in order to plan the surgery. In case participant has not made those tests- the investigator fills a written request to do so. then, the investigator will perform a neck ultrasound and identifies the pathological parathyroid gland. The suspected pathological gland is aspirated using a 27 gauge needle attached to a 5 cc syringe fills with 1 cc saline (0.9% NaCL) under the guidance of the ultrasound. The aspirated material is sent for 2 examinations:

  1. parathyroid hormone level: the aspirated material is injected into a ethylenediaminetetraacetic acid (EDTA) vial and send to the hospital's endocrine laboratory. the parathyroid hormone level is processed using chemiluminescence method and represented in Pg/ml units.
  2. cytology examination. The aspirated material is spread on a glassed slide and prepared with a Giemsa stain for a cytologic examination. cytologic features such as cell type, cytoplasmic characteristics,cell block structure and chromatin appearance is addressed by the pathologist.

After completion of the ultrasound - guided needle aspiration the participant is given an exact date for the surgery.

The surgery is carried out routinely with the same surgical steps that the investigator is familiar with. At the end of surgery, after the pathological parathyroid gland was extracted from the neck, it is aspirated with a 27Gy needle attached to a 5 cc, syringe filled with a 1 cc saline (0.9% NaCL).

The aspirated material is sent to the same, above mentioned, examinations (parathyroid hormone level and cytology).

After the investigator receives the final pathological result of the suspected gland and confirm that the excised tissue was indeed a pathological parathyroid one, the investigators are able to answer 2 important questions:

  1. Is high level of parathyroid hormone which was aspirated from a suspected pathological parathyroid tissue is a good indicator that the tissue is indeed a pathological parathyroid.
  2. Is there a difference between parathyroid cytology of a tissue aspirated transcutaneously to a parathyroid cytology of material aspirated directly from the parathyroid gland.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 1834111
        • Haemek Medical Center

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 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • above 18 years old
  • participants that suffer from primary hyperparathyroidism with an indication for parathyroidectomy

Exclusion Criteria:

  • Chronic renal failure
  • kidney transplant participant
  • MEN (multiple endocrine neoplasia) syndrome
  • pregnancy

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: investigation group
participants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial
Diagnostic test: pre operative parathyroid hormone level measurement
At the clinic, the participants will undergo ultrasound examination with fine needle aspiration. The aspirated material will be sent for parathyroid hormone level measurement.
Diagnostic test: pre operative parathyroid cytology
At the clinic, the participants will undergo neck ultrasound examination with fine needle aspiration. The aspirated material will be sent for cytology examination.
Diagnostic test: parathyroid hormone level measurement
At surgery, after the pathologic gland is excised , the gland will be aspirated. The material will be sent for parathyroid hormone level measurement.
Diagnostic test: parathyroid cytology
At surgery, after the pathologic gland is excised , it will be aspirated again for cytologic examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parathyroid hormone level from a pathological parathyroid gland
Time Frame: one month after the patient starts the study
Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.The investigators will aspirate material from this gland and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland. thereby, this method may replace other localization methods
one month after the patient starts the study
parathyroid hormone level from a pathological parathyroid gland
Time Frame: one month after the patient starts the study
At surgical final step, after the pathological parathyroid gland is ex vivo the investigator will aspirate material from it and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland.
one month after the patient starts the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parathyroid gland cytology from a pathological parathyroid gland.
Time Frame: one month after the patient starts the study
Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.The investigators will aspirate material from this gland and send it for cytology examination.By doing so we will investigate whether cytology that was aspirated from parathyroid gland trans cutaneously is different from a cytology of the gland aspirated directly (ex vivo-after it the gland excised from the body).
one month after the patient starts the study
parathyroid gland cytology
Time Frame: one month after the patient starts the study
At surgical final step, after the pathological parathyroid gland is ex vivo the investigator will aspirate material from it and send it for cytology examination.By doing so the investigators will determine whether cytology that was aspirated from parathyroid gland trans cutaneously is different from a cytology of the gland aspirated directly (ex vivo- after it the gland excised from the body).
one month after the patient starts the study

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Study Director: Dror Ashkenazi, M.D, Haemek Medical Center

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)

June 9, 2018

Primary Completion (ACTUAL)

April 9, 2020

Study Completion (ACTUAL)

August 9, 2020

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (ACTUAL)

May 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0005-EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will not make individual participant data available due to the desire to preserve the privacy of the participants in the study

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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