Multigland Disease in Primary HyperparathyroidismNCT01484379
Surgical Approach for Primary Hyperparathyroidism in the Elderly
A study testing unilateral neck exploration in people with Multigland Disease in Primary Hyperparathyroidism, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multigland Disease in Primary Hyperparathyroidism
- What is being tested?
- unilateral neck exploration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Nov 2015
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patient with primary hyperparathyroidism.
- patients with an indication for surgery.
- Suspected adenoma on preop images.
- minimum age of 65.
Who cannot join
- patients younger than 65.
- cases where imaging didn't locate any adenoma.
- patients who did not consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study
Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly.
This study will include patients over the age of 65, diagnosed with primary hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected followed by an exploration of the other gland at the same time. Data will be analysed to determine the frequency of multigland disease in this population.
- Being tested
- unilateral neck exploration
- Keywords
- Primary Hyperparathyroidism, multigland disease, neck exploration, elderly
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral neck explorationProcedure or surgery
All elderly patients with primary hyperparathyroidism suspected to have a single gland disease will have a unilateral neck exploration following the index gland identification.
| Study group | Role | What they receive |
|---|---|---|
| unilateral neck exploration | Experimental | unilateral neck exploration of elderly with primary hyperparathyroidism Receives: Procedure: unilateral neck exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of multigland disease in hyperparathyroidism in the elderly.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: difficulties in Recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multigland Disease in 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Mekel, M.D, Principal investigator, Rambam health care campus Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484379
- Sponsor's protocol ID
- parathyroid409-11-RMBCTIL
- Status last verified
- Aug 2017
- First submitted
- 1 Dec 2011
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kebebew E, Duh QY, Clark OH. Parathyroidectomy for primary hyperparathyroidism in octogenarians and nonagenarians: a plea for early surgical referral. Arch Surg. 2003 Aug;138(8):867-71. doi: 10.1001/archsurg.138.8.867.
PubMed 12912745Shin SH, Holmes H, Bao R, Jimenez C, Kee SS, Potylchansky E, Lee JE, Evans DB, Perrier ND. Outpatient minimally invasive parathyroidectomy is safe for elderly patients. J Am Coll Surg. 2009 Jun;208(6):1071-6. doi: 10.1016/j.jamcollsurg.2009.01.048. Epub 2009 Apr 17.
PubMed 19476894Uden P, Chan A, Duh QY, Siperstein A, Clark OH. Primary hyperparathyroidism in younger and older patients: symptoms and outcome of surgery. World J Surg. 1992 Jul-Aug;16(4):791-7; discussion 798. doi: 10.1007/BF02067389.
PubMed 1413850
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study
- ClinicalTrials.gov ID
- NCT01484379
- Acronym / sponsor ID
- parathyroid409-11-RMBCTIL
- Keywords
- Primary Hyperparathyroidism, multigland disease, neck exploration, elderly
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulties in Recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Dec 2011 (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.
Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly.
This study will include patients over the age of 65, diagnosed with primary hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected followed by an exploration of the other gland at the same time. Data will be analysed to determine the frequency of multigland disease in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unilateral neck exploration | Experimental | Procedure: unilateral neck explorationunilateral neck exploration of elderly with primary hyperparathyroidism |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patient with primary hyperparathyroidism.
- patients with an indication for surgery.
- Suspected adenoma on preop images.
- minimum age of 65.
Key exclusion criteria (3 listed)
- patients younger than 65.
- cases where imaging didn't locate any adenoma.
- patients who did not consent to participate in the study.
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 |
|---|---|---|
| unilateral neck explorationAll elderly patients with primary hyperparathyroidism suspected to have a single gland disease will have a unilateral neck exploration following the index gland identification. | Procedure or surgery | unilateral neck exploration |
Primary outcome
Frequency of multigland disease in hyperparathyroidism in the elderly.
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Background: PubMed 12912745Kebebew E, Duh QY, Clark OH. Parathyroidectomy for primary hyperparathyroidism in octogenarians and nonagenarians: a plea for early surgical referral. Arch Surg. 2003 Aug;138(8):867-71. doi: 10.1001/archsurg.138.8.867.
- Background: PubMed 19476894Shin SH, Holmes H, Bao R, Jimenez C, Kee SS, Potylchansky E, Lee JE, Evans DB, Perrier ND. Outpatient minimally invasive parathyroidectomy is safe for elderly patients. J Am Coll Surg. 2009 Jun;208(6):1071-6. doi: 10.1016/j.jamcollsurg.2009.01.048. Epub 2009 Apr 17.
- Background: PubMed 1413850Uden P, Chan A, Duh QY, Siperstein A, Clark OH. Primary hyperparathyroidism in younger and older patients: symptoms and outcome of surgery. World J Surg. 1992 Jul-Aug;16(4):791-7; discussion 798. doi: 10.1007/BF02067389.
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.
Michal Mekel, M.D principal investigator
Rambam health care campus Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral neck exploration in people with Multigland Disease in Primary Hyperparathyroidism, run by Rambam Health Care Campus at 1 site in Israel.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Aug 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of multigland disease in hyperparathyroidism in the elderly. (time frame: two years). 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 NCT01484379, which also lists 3 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 Aug 2017.