Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland
Primary Purpose
Parathyroid Adenoma, Hypercalcemia
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
pre operative parathyroid hormone level measurement
pre operative parathyroid cytology
parathyroid hormone level measurement
parathyroid cytology
Sponsored by
About this trial
This is an interventional diagnostic trial for Parathyroid Adenoma focused on measuring cytology, parathyroidectomy, parathyroid hormone level
Eligibility 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
Sites / Locations
- Haemek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
investigation group
Arm Description
participants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT03516747
First Posted
April 3, 2018
Last Updated
April 3, 2022
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT03516747
Brief Title
Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland
Official Title
Ultrasound Guided Fine Needle Aspiration of Parathyroid Gland as a Pre Operative Localization Tool to Identify Pathological Parathyroid
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
we gave up
Study Start Date
June 9, 2018 (Actual)
Primary Completion Date
April 9, 2020 (Actual)
Study Completion Date
August 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Adenoma, Hypercalcemia
Keywords
cytology, parathyroidectomy, parathyroid hormone level
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open label, non- randomised, prospective
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
investigation group
Arm Type
Experimental
Arm Description
participants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial
Intervention Type
Diagnostic Test
Intervention Name(s)
pre operative parathyroid hormone level measurement
Intervention Description
At the clinic, the participants will undergo ultrasound examination with fine needle aspiration. The aspirated material will be sent for parathyroid hormone level measurement.
Intervention Type
Diagnostic Test
Intervention Name(s)
pre operative parathyroid cytology
Intervention Description
At the clinic, the participants will undergo neck ultrasound examination with fine needle aspiration. The aspirated material will be sent for cytology examination.
Intervention Type
Diagnostic Test
Intervention Name(s)
parathyroid hormone level measurement
Intervention Description
At surgery, after the pathologic gland is excised , the gland will be aspirated. The material will be sent for parathyroid hormone level measurement.
Intervention Type
Diagnostic Test
Intervention Name(s)
parathyroid cytology
Intervention Description
At surgery, after the pathologic gland is excised , it will be aspirated again for cytologic examination.
Primary Outcome Measure Information:
Title
parathyroid hormone level from a pathological parathyroid gland
Description
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
Title
parathyroid hormone level from a pathological parathyroid gland
Description
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
Secondary Outcome Measure Information:
Title
parathyroid gland cytology from a pathological parathyroid gland.
Description
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
Title
parathyroid gland cytology
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Ashkenazi, M.D
Organizational Affiliation
haemek medical center
Official's Role
Study Director
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Learn more about this trial
Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland
We'll reach out to this number within 24 hrs