Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03516747

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parathyroid Adenoma Hypercalcemia	Diagnostic Test: pre operative parathyroid hormone level measurement Diagnostic Test: pre operative parathyroid cytology Diagnostic Test: parathyroid hormone level measurement Diagnostic Test: parathyroid cytology	N/A

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:

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.
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:

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.
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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

open label, non- randomised, prospectiveopen label, non- randomised, prospective

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 9, 2018

Actual Primary Completion Date :

Apr 9, 2020

Actual Study Completion Date :

Aug 9, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

parathyroid hormone level from a pathological parathyroid gland [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
parathyroid hormone level from a pathological parathyroid gland [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.

Secondary Outcome Measures

parathyroid gland cytology from a pathological parathyroid gland. [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).
parathyroid gland cytology [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).