An interventional study of pre operative parathyroid hormone level measurement and pre operative parathyroid cytology in Parathyroid Adenoma and Hypercalcemia, sponsored by HaEmek Medical Center, Israel. Withdrawn at 1 site in Israel. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Diagnostic
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.
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:
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:
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Exclusion Criteria:
participants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial
Diagnostic Test: pre operative parathyroid hormone level measurement · Diagnostic Test: pre operative parathyroid cytology · Diagnostic Test: parathyroid hormone level measurement · Diagnostic Test: parathyroid cytology
At the clinic, the participants will undergo ultrasound examination with fine needle aspiration. The aspirated material will be sent for parathyroid hormone level measurement.
At the clinic, the participants will undergo neck ultrasound examination with fine needle aspiration. The aspirated material will be sent for cytology examination.
At surgery, after the pathologic gland is excised , the gland will be aspirated. The material will be sent for parathyroid hormone level measurement.
At surgery, after the pathologic gland is excised , it will be aspirated again for cytologic examination.
parathyroid hormone level from a pathological parathyroid gland
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
Time frame: one month after the patient starts the study
parathyroid hormone level from a pathological parathyroid gland
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.
Time frame: one month after the patient starts the study
parathyroid gland cytology from a pathological parathyroid gland.
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).
Time frame: one month after the patient starts the study
parathyroid gland cytology
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).
Time frame: one month after the patient starts the study
Plan to share: No — The investigators will not make individual participant data available due to the desire to preserve the privacy of the participants in the study
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This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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