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Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516747
Recruitment Status : Unknown
Verified May 2018 by Paker Miki, HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Paker Miki, HaEmek Medical Center, Israel

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open 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
Estimated Study Start Date : June 9, 2018
Estimated Primary Completion Date : April 9, 2020
Estimated Study Completion Date : August 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516747


Contacts
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Contact: miki paker, M.D 972-52-6596552 chiefmiki2014@gmail.com

Locations
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Israel
Haemek Medical Center
Afula, Israel, 1834111
Contact: salim mazzawi, MD    972-4-6494311    salim_ma@clalit.org.il   
Contact: Dror Ashkenazi, MD    972-4-6495530    dror_as@clalit.org.il   
Principal Investigator: Miki Paker, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Study Director: Dror Ashkenazi, M.D haemek medical center
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Responsible Party: Paker Miki, Dr.paker miki. principal investigator, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03516747    
Other Study ID Numbers: 18-0005-EMC
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paker Miki, HaEmek Medical Center, Israel:
cytology
parathyroidectomy
parathyroid hormone level
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hypercalcemia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Parathyroid Diseases
Hormones
Parathyroid Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents