Primary HyperparathyroidismMIRPNCT01530919
Minimally Invasive Radioguided Parathyroidectomy
An observational study of Primary Hyperparathyroidism, run by University of Louisville at 1 site in United States.
Trial summary
The main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). The researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- Minimally invasive radioguided parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 856 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and minors diagnosed with primary hyperparathyroidism that will be having minimally invasive radioguided parathyroidectomy surgery to correct this condition at either Norton Hospital, University of Louisville Hospital or Jewish Hospital.
Who may be able to join
- All patients with biochemical evidence of primary hyperparathyroidism
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
The main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). The researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s).
Read the detailed description
The specific aims of this study are to determine the safety and efficacy of minimally invasive radioguided parathyroidectomy, to determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas, and to differentiate adenomas from parathyroid hyperplasia. In addition, this study aims to determine the value of intraoperative parathyroid hormone assay to verify biochemical cure of primary hyperparathyroidism, to determine whether minimally invasive radioguided parathyroidectomy is cos-effective, and to collect abnormal parathyroid tissue at the time of surgery for tissue analysis.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- Minimally invasive radioguided parathyroidectomy
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive radioguided parathyroidectomyProcedure or surgery
After the patient is prepared for surgery and under local anesthesia, the initial incision by the surgeon will be 2-3 cm. The surgeon will dissect in the designated quadrant until the parathyroid gland is identified.
| Study group | Role | What they receive |
|---|---|---|
| Parathyroid surgery | Database of patients who have undergone minimally invasive radioguided parathyroidectomy Receives: Procedure: Minimally invasive radioguided parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas.
Measured: 2-3days
Secondary outcomes (2)
The value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism
Measured: 2-3 days
Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis
Measured: day of surgery (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startSep 1998
- Primary completionDec 2009
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 856 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Norton Healthcare, Jewish Hospital and St. Mary's Healthcare
- Responsible party
- Principal investigator, Michael B. Flynn, MD, University of Louisville
- Investigators
- Michael J Flynn, M.D., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530919
- Sponsor's protocol ID
- 291.97
- Acronym
- MIRP
- Status last verified
- May 2017
- First submitted
- 30 Nov 2011
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Quillo AR, Bumpous JM, Goldstein RE, Fleming MM, Flynn MB. Minimally invasive parathyroid surgery, the Norman 20% rule: is it valid? Am Surg. 2011 Apr;77(4):484-7.
PubMed 21679561Grady JA, Bumpous JM, Fleming MM, Flynn MB, Turbiner E, Lentsch EJ, Ziegler CH. Advantages of a targeted approach in minimally invasive radioguided parathyroidectomy surgery for primary hyperparathyroidism. Laryngoscope. 2006 Mar;116(3):431-5. doi: 10.1097/01.mlg.0000195288.06601.18.
PubMed 16540904Flynn MB, Quayyum M, Goldstein RE, Bumpous JM. Outpatient parathyroid surgery: ten-year experience: is it safe? Am Surg. 2015 May;81(5):472-7.
PubMed 25975331Flynn MB, Bumpous JM, Schill K, McMasters KM. Minimally invasive radioguided parathyroidectomy. J Am Coll Surg. 2000 Jul;191(1):24-31. doi: 10.1016/s1072-7515(00)00297-0.
PubMed 10898180Hutchinson JR, Yandell DW, Bumpous JM, Fleming MM, Flynn MB. Three-year financial analysis of minimally invasive radio-guided parathyroidectomy. Am Surg. 2004 Dec;70(12):1112-5.
PubMed 15663056Goldstein RE, Carter WM 2nd, Fleming M, Bumpous J, Lentsch E, Rice M, Flynn M. Unilateral cervical surgical exploration aided by intraoperative parathyroid hormone monitoring in patients with primary hyperparathyroidism and equivocal sestamibi scan results. Arch Surg. 2006 Jun;141(6):552-7; discussion 557-9. doi: 10.1001/archsurg.141.6.552.
PubMed 16785355Kartha SS, Chacko CE, Bumpous JM, Fleming M, Lentsch EJ, Flynn MB. Toxic metabolic encephalopathy after parathyroidectomy with methylene blue localization. Otolaryngol Head Neck Surg. 2006 Nov;135(5):765-8. doi: 10.1016/j.otohns.2006.05.026.
PubMed 17071309Conn CA, Clark J, Bumpous J, Goldstein R, Fleming M, Flynn MB. Hypocalcemia after neck exploration for untreated primary hyperparathyroidism. Am Surg. 2006 Dec;72(12):1234-7.
PubMed 17216827Han N, Bumpous JM, Goldstein RE, Fleming MM, Flynn MB. Intra-operative parathyroid identification using methylene blue in parathyroid surgery. Am Surg. 2007 Aug;73(8):820-3.
PubMed 17879694Stephen ET, Quillo AR, Lewis KE, Harden FL, Bumpous JM, Flynn MB, Callender GG. Operative failure rate and documentation of family history in young patients undergoing focused parathyroidectomy for primary hyperparathyroidism. Am Surg. 2015 Jun;81(6):585-90.
PubMed 26031271Bumpous JM, Goldstein RL, Flynn MB. Surgical and calcium outcomes in 427 patients treated prospectively in an image-guided and intraoperative PTH (IOPTH) supplemented protocol for primary hyperparathyroidism: outcomes and opportunities. Laryngoscope. 2009 Feb;119(2):300-6. doi: 10.1002/lary.20049.
PubMed 19160424Young VN, Osborne KM, Fleming MM, Flynn MB, Goldstein RE, Bumpous JM. Parathyroidectomy in the elderly population: does age really matter? Laryngoscope. 2010 Feb;120(2):247-52. doi: 10.1002/lary.20706.
PubMed 19950385
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Radioguided Parathyroidectomy
- ClinicalTrials.gov ID
- NCT01530919
- Acronym / sponsor ID
- MIRP / 291.97
- Conditions
- Primary Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 856 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Norton Healthcare, Jewish Hospital and St. Mary's Healthcare
- Study start
- Sep 1998
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Feb 2012 (estimated)
- 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.
The main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). The researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s).
Detailed description
The specific aims of this study are to determine the safety and efficacy of minimally invasive radioguided parathyroidectomy, to determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas, and to differentiate adenomas from parathyroid hyperplasia. In addition, this study aims to determine the value of intraoperative parathyroid hormone assay to verify biochemical cure of primary hyperparathyroidism, to determine whether minimally invasive radioguided parathyroidectomy is cos-effective, and to collect abnormal parathyroid tissue at the time of surgery for tissue analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parathyroid surgery | – | Procedure: Minimally invasive radioguided parathyroidectomyDatabase of patients who have undergone minimally invasive radioguided parathyroidectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and minors diagnosed with primary hyperparathyroidism that will be having minimally invasive radioguided parathyroidectomy surgery to correct this condition at either Norton Hospital, University of Louisville Hospital or Jewish Hospital.
Key inclusion criteria (1 listed)
- All patients with biochemical evidence of primary hyperparathyroidism
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Minimally invasive radioguided parathyroidectomyAfter the patient is prepared for surgery and under local anesthesia, the initial incision by the surgeon will be 2-3 cm. The surgeon will dissect in the designated quadrant until the parathyroid gland is identified. | Procedure or surgery | Parathyroid surgery |
Primary outcome
The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas.
Time frame: 2-3days
2 secondary outcomes
The value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism
Time frame: 2-3 days
Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis
Time frame: day of surgery (1 day)
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 4 May 2017.
- Results publication: PubMed 21679561Quillo AR, Bumpous JM, Goldstein RE, Fleming MM, Flynn MB. Minimally invasive parathyroid surgery, the Norman 20% rule: is it valid? Am Surg. 2011 Apr;77(4):484-7.
- Results publication: PubMed 16540904Grady JA, Bumpous JM, Fleming MM, Flynn MB, Turbiner E, Lentsch EJ, Ziegler CH. Advantages of a targeted approach in minimally invasive radioguided parathyroidectomy surgery for primary hyperparathyroidism. Laryngoscope. 2006 Mar;116(3):431-5. doi: 10.1097/01.mlg.0000195288.06601.18.
- Results publication: PubMed 25975331Flynn MB, Quayyum M, Goldstein RE, Bumpous JM. Outpatient parathyroid surgery: ten-year experience: is it safe? Am Surg. 2015 May;81(5):472-7.
- Results publication: PubMed 10898180Flynn MB, Bumpous JM, Schill K, McMasters KM. Minimally invasive radioguided parathyroidectomy. J Am Coll Surg. 2000 Jul;191(1):24-31. doi: 10.1016/s1072-7515(00)00297-0.
- Results publication: PubMed 15663056Hutchinson JR, Yandell DW, Bumpous JM, Fleming MM, Flynn MB. Three-year financial analysis of minimally invasive radio-guided parathyroidectomy. Am Surg. 2004 Dec;70(12):1112-5.
- Results publication: PubMed 16785355Goldstein RE, Carter WM 2nd, Fleming M, Bumpous J, Lentsch E, Rice M, Flynn M. Unilateral cervical surgical exploration aided by intraoperative parathyroid hormone monitoring in patients with primary hyperparathyroidism and equivocal sestamibi scan results. Arch Surg. 2006 Jun;141(6):552-7; discussion 557-9. doi: 10.1001/archsurg.141.6.552.
- Results publication: PubMed 17071309Kartha SS, Chacko CE, Bumpous JM, Fleming M, Lentsch EJ, Flynn MB. Toxic metabolic encephalopathy after parathyroidectomy with methylene blue localization. Otolaryngol Head Neck Surg. 2006 Nov;135(5):765-8. doi: 10.1016/j.otohns.2006.05.026.
- Results publication: PubMed 17216827Conn CA, Clark J, Bumpous J, Goldstein R, Fleming M, Flynn MB. Hypocalcemia after neck exploration for untreated primary hyperparathyroidism. Am Surg. 2006 Dec;72(12):1234-7.
- Results publication: PubMed 17879694Han N, Bumpous JM, Goldstein RE, Fleming MM, Flynn MB. Intra-operative parathyroid identification using methylene blue in parathyroid surgery. Am Surg. 2007 Aug;73(8):820-3.
- Results publication: PubMed 26031271Stephen ET, Quillo AR, Lewis KE, Harden FL, Bumpous JM, Flynn MB, Callender GG. Operative failure rate and documentation of family history in young patients undergoing focused parathyroidectomy for primary hyperparathyroidism. Am Surg. 2015 Jun;81(6):585-90.
- Results publication: PubMed 19160424Bumpous JM, Goldstein RL, Flynn MB. Surgical and calcium outcomes in 427 patients treated prospectively in an image-guided and intraoperative PTH (IOPTH) supplemented protocol for primary hyperparathyroidism: outcomes and opportunities. Laryngoscope. 2009 Feb;119(2):300-6. doi: 10.1002/lary.20049.
- Results publication: PubMed 19950385Young VN, Osborne KM, Fleming MM, Flynn MB, Goldstein RE, Bumpous JM. Parathyroidectomy in the elderly population: does age really matter? Laryngoscope. 2010 Feb;120(2):247-52. doi: 10.1002/lary.20706.
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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.
Michael J Flynn, M.D. principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by University of Louisville at 1 site in United States.
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 0 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas. (time frame: 2-3days). 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 NCT01530919, which also lists 12 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 4 May 2017.