Mediastinal Parathyroid AdenomaNCT05696405
VATS for Resection of Mediastinal Parathyroids
An observational study of Mediastinal Parathyroid Adenoma and Hyperparathyroidism, run by Hospital General Ajusco Medio.
Trial summary
Background: hyperparathyroidism (HPT) is a disease caused by hypersecretion of one or more parathyroid glands, it can be associated with ectopic mediastinal parathyroid glands (MEPA) in 2% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Parathyroid Adenoma, Hyperparathyroidism
- What is being tested?
- VATS resection of MEPA
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with MEPA and treated by VATS approach was performed in a tertiary hospital in Mexico City.
Who may be able to join
- Patients with MEPA
Who cannot join
- incomplete records
About this study
Official title: Thoracoscopic Treatment of Mediastinal Ectopic Parathyroid Adenomas: A Case Series and Literature Review
Background: hyperparathyroidism (HPT) is a disease caused by hypersecretion of one or more parathyroid glands, it can be associated with ectopic mediastinal parathyroid glands (MEPA) in 2% of cases. The use of video-assisted thoracoscopic surgery (VATS) for the surgical resection of these glands is a safe, cost-effective, and low-morbidity option for patients with MEPA. We report a case series of patients with this disease managed with VATS.
Patients \& Methods: From 2008 to 2022, a retrospective study involving patients with MEPA and treated by VATS approach was performed in a tertiary hospital in Mexico City. Relevant biochemical and clinical variables such as imaging studies, pre and postoperative lab results, surgical strategy and outcomes, and pathological analyses were analyzed.
Read the detailed description
Hyperparathyroidism (HPT) is a clinical disorder characterized by an inappropriately elevated paratohormone (PTH) due to hypersecretion of one or more parathyroid glands, that may develop secondary hypercalcemia and other metabolic disturbances. This disease includes various signs and symptoms such as nephrolithiasis, osteopenia and osteoporosis, depression, mental numbness, loss of appetite, nausea, vomiting, constipation among others. The abnormal secretion of PTH is most commonly caused by a single parathyroid gland adenoma in 85% of the cases, in the other 15% is due to multiple gland hyperplasia (15-20%)(1) or rarely from a parathyroid carcinoma (<1%). HPT occurs in both genders equally around the sixth decade(2). World HPT prevalence is estimated at 1 in every 500 women and 1 in every 2000 men(3).
Mediastinal ectopic parathyroid adenomas (MEPA) are rare tumors, constituting 1-2% of all parathyroid adenomas. These glands are inferior to the sternal notch and their location may vary from the superior mediastinum to the pericardium and diaphragm(4). The first report of a mediastinal parathyroid adenoma was in 1932 by Churchill in the patient Captain Charles E. Martell, who had 6 prior cervical explorations for his hyperparathyroidism until an ectopic gland was found in the superior mediastinum(5). Before the introduction of VATS, MEPA were usually resected by thoracotomy or a median sternotomy, currently with the daily use of minimally invasive surgery, VATS is being adopted as the procedure of choice.
The aim of this study to report a case series of patients with MEPA treated with VATS, along with a literature review.
- Being tested
- VATS resection of MEPA
- Keywords
- hyperparathyroidism, Video-assisted thoracoscopy surgery, Mediastinal ectopic parathyroid adenoma
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS resection of MEPAProcedure or surgery
VATS resection of mediastinal parathyroid adenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical cure of hyperparathyroidism
Normalization of Paratohormone leves
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Jan 2008
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mediastinal Parathyroid AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Ajusco Medio
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Responsible party
- Principal investigator, Karla Verónica Chavez-Tostado, Hospital Reg. Lic. Adolfo Lopez Mateos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696405
- Sponsor's protocol ID
- 004
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kitada M, Yasuda S, Nana T, Ishibashi K, Hayashi S, Okazaki S. Surgical treatment for mediastinal parathyroid adenoma causing primary hyperparathyroidism. J Cardiothorac Surg. 2016 Apr 7;11:44. doi: 10.1186/s13019-016-0461-8.
PubMed 27056365Long KL, Lee CY, Ramaiah C, Sloan DA. Intrapericardial parathyroid adenomadagger. J Surg Case Rep. 2013 Aug 29;2013(8):rjt064. doi: 10.1093/jscr/rjt064.
PubMed 24964470Hu J, Ngiam KY, Parameswaran R. Mediastinal parathyroid adenomas and their surgical implications. Ann R Coll Surg Engl. 2015 May;97(4):259-61. doi: 10.1308/003588415X14181254789088.
PubMed 26263931Spence HM. The life and death of Captain Charles Martell and kidney stone disease. J Urol. 1984 Dec;132(6):1204-7. doi: 10.1016/s0022-5347(17)50098-1.
PubMed 6389906Sreevathsa MR, Melanta K. Unilateral Exploration for Parathyroid Adenoma. Indian J Surg Oncol. 2017 Jun;8(2):142-145. doi: 10.1007/s13193-016-0605-2. Epub 2016 Dec 27.
PubMed 28546708Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.
PubMed 27532368Medrano C, Hazelrigg SR, Landreneau RJ, Boley TM, Shawgo T, Grasch A. Thoracoscopic resection of ectopic parathyroid glands. Ann Thorac Surg. 2000 Jan;69(1):221-3. doi: 10.1016/s0003-4975(99)01127-3.
PubMed 10654517
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Treatment of Mediastinal Ectopic Parathyroid Adenomas: A Case Series and Literature Review
- ClinicalTrials.gov ID
- NCT05696405
- Acronym / sponsor ID
- 004
- Keywords
- hyperparathyroidism, Video-assisted thoracoscopy surgery, Mediastinal ectopic parathyroid adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospital General Ajusco MedioUniversity, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: hyperparathyroidism (HPT) is a disease caused by hypersecretion of one or more parathyroid glands, it can be associated with ectopic mediastinal parathyroid glands (MEPA) in 2% of cases. The use of video-assisted thoracoscopic surgery (VATS) for the surgical resection of these glands is a safe, cost-effective, and low-morbidity option for patients with MEPA. We report a case series of patients with this disease managed with VATS.
Patients \& Methods: From 2008 to 2022, a retrospective study involving patients with MEPA and treated by VATS approach was performed in a tertiary hospital in Mexico City. Relevant biochemical and clinical variables such as imaging studies, pre and postoperative lab results, surgical strategy and outcomes, and pathological analyses were analyzed.
Detailed description
Hyperparathyroidism (HPT) is a clinical disorder characterized by an inappropriately elevated paratohormone (PTH) due to hypersecretion of one or more parathyroid glands, that may develop secondary hypercalcemia and other metabolic disturbances. This disease includes various signs and symptoms such as nephrolithiasis, osteopenia and osteoporosis, depression, mental numbness, loss of appetite, nausea, vomiting, constipation among others. The abnormal secretion of PTH is most commonly caused by a single parathyroid gland adenoma in 85% of the cases, in the other 15% is due to multiple gland hyperplasia (15-20%)(1) or rarely from a parathyroid carcinoma (<1%). HPT occurs in both genders equally around the sixth decade(2). World HPT prevalence is estimated at 1 in every 500 women and 1 in every 2000 men(3).
Mediastinal ectopic parathyroid adenomas (MEPA) are rare tumors, constituting 1-2% of all parathyroid adenomas. These glands are inferior to the sternal notch and their location may vary from the superior mediastinum to the pericardium and diaphragm(4). The first report of a mediastinal parathyroid adenoma was in 1932 by Churchill in the patient Captain Charles E. Martell, who had 6 prior cervical explorations for his hyperparathyroidism until an ectopic gland was found in the superior mediastinum(5). Before the introduction of VATS, MEPA were usually resected by thoracotomy or a median sternotomy, currently with the daily use of minimally invasive surgery, VATS is being adopted as the procedure of choice.
The aim of this study to report a case series of patients with MEPA treated with VATS, along with a literature review.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with MEPA and treated by VATS approach was performed in a tertiary hospital in Mexico City.
Key inclusion criteria (1 listed)
- Patients with MEPA
Key exclusion criteria (1 listed)
- incomplete records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATS resection of MEPAVATS resection of mediastinal parathyroid adenoma | Procedure or surgery | – |
Primary outcome
Biochemical cure of hyperparathyroidism
Time frame: 24hours
Normalization of Paratohormone leves
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Results publication: PubMed 27056365Kitada M, Yasuda S, Nana T, Ishibashi K, Hayashi S, Okazaki S. Surgical treatment for mediastinal parathyroid adenoma causing primary hyperparathyroidism. J Cardiothorac Surg. 2016 Apr 7;11:44. doi: 10.1186/s13019-016-0461-8.
- Results publication: PubMed 24964470Long KL, Lee CY, Ramaiah C, Sloan DA. Intrapericardial parathyroid adenomadagger. J Surg Case Rep. 2013 Aug 29;2013(8):rjt064. doi: 10.1093/jscr/rjt064.
- Results publication: PubMed 26263931Hu J, Ngiam KY, Parameswaran R. Mediastinal parathyroid adenomas and their surgical implications. Ann R Coll Surg Engl. 2015 May;97(4):259-61. doi: 10.1308/003588415X14181254789088.
- Results publication: PubMed 6389906Spence HM. The life and death of Captain Charles Martell and kidney stone disease. J Urol. 1984 Dec;132(6):1204-7. doi: 10.1016/s0022-5347(17)50098-1.
- Results publication: PubMed 28546708Sreevathsa MR, Melanta K. Unilateral Exploration for Parathyroid Adenoma. Indian J Surg Oncol. 2017 Jun;8(2):142-145. doi: 10.1007/s13193-016-0605-2. Epub 2016 Dec 27.
- Results publication: PubMed 27532368Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.
- Results publication: PubMed 10654517Medrano C, Hazelrigg SR, Landreneau RJ, Boley TM, Shawgo T, Grasch A. Thoracoscopic resection of ectopic parathyroid glands. Ann Thorac Surg. 2000 Jan;69(1):221-3. doi: 10.1016/s0003-4975(99)01127-3.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal Parathyroid Adenoma and Hyperparathyroidism, run by Hospital General Ajusco Medio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical cure of hyperparathyroidism (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696405, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.