Hyperparathyroidism, SecondaryNCT02464072
Subtotal Parathyroidectomy or Total Parathyroidectomy With Autograft in Chronic Kidney Disease Patients Under Dialysis
A study testing Subtotal Parathyroidectomy, Total Parathyroidectomy + 45 autografts and Total Parathyroidectomy + 90 autografts in people with Hyperparathyroidism, Secondary, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study evaluates the metabolic and clinical results of two well recognized and accepted surgical techniques in the management of severe hyperparathyroidism in patients under regular dialysis treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperparathyroidism, Secondary
- What is being tested?
- Subtotal Parathyroidectomy, Total Parathyroidectomy + 45 autografts and Total Parathyroidectomy + 90 autografts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage V Chronic Kidney Disease patients under regular dialysis treatment with severe hyperparathyroidism requiring parathyroidectomy
Who cannot join
- patients refusing to participate in the study (they will receive standard surgery),
- patients unable to attend regular follow up consultations,
- patients with a successful kidney transplant at the moment of parathyroidectomy,
- patients submitted to any previous surgery of the thyroid or parathyroid,
- patients with chronic kidney disease but not under dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Subtotal Parathyroidectomy or Total Parathyroidectomy With Immediate Heterotopic Autograft in Chronic Renal Disease Patients Stage V Under Dialysis
This study evaluates the metabolic and clinical results of two well recognized and accepted surgical techniques in the management of severe hyperparathyroidism in patients under regular dialysis treatment.
Read the detailed description
Prospective randomized trial in the surgical management of severe hyperparathyroidism of chronic kidney disease stage V under dialysis. Patients will be randomized and they will be submitted to subtotal parathyroidectomy or total parathyroidectomy with immediate heterotopic autograft of 45 or 90 fragments of parathyroid tissue.
- Conditions
- Hyperparathyroidism, Secondary
- Being tested
- Subtotal Parathyroidectomy, Total Parathyroidectomy + 45 autografts, Total Parathyroidectomy + 90 autografts
- Keywords
- Parathyroidectomy, Renal Insufficiency, Chronic
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtotal ParathyroidectomyProcedure or surgery
Subtotal parathyroid resection leaving the estimated mass of two normal parathyroid glands in situ. The type of operation is the intervention. No new device or drug is involved.
Total Parathyroidectomy + 45 autograftsProcedure or surgery
Immediate autograft of 45 fragments of parathyroid tissue, after a total parathyroidectomy.This type of operation is the standard intervention at the institution at the moment. No new device or drug is involved.
Total Parathyroidectomy + 90 autograftsProcedure or surgery
Immediate autograft of 90 fragments of parathyroid tissue, after a total parathyroidectomy.The type of operation is the intervention. No new device or drug is involved.
| Study group | Role | What they receive |
|---|---|---|
| Subtotal Parathyroidectomy | Experimental | Patients will be submitted to subtotal parathyroidectomy. The intention is to leave a parathyroid remanent equivalent to two normal parathyroid glands in situ. The type of the operation is the intervention. No drugs or devices are tested. Receives: Procedure: Subtotal Parathyroidectomy |
| Total Parathyroidectomy + 45 autografts | Active comparator | Patients will be submitted to a total parathyroidectomy and 45 fragments of parathyroid tissue are grafted in the forearm. This is the current standard treatment at the institution for severe secondary hyperparathyroidism.The type of operation is the intervention itself. No new device or drug is involved. Receives: Procedure: Total Parathyroidectomy + 45 autografts |
| Total Parathyroidectomy + 90 autografts | Experimental | Patients will be submitted to a total parathyroidectomy and 90 fragments of parathyroid tissue are grafted in the forearm. The type of operation is the intervention. No new device or drug is involved. . Receives: Procedure: Total Parathyroidectomy + 90 autografts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Five years survival after parathyroidectomy in an intention to treat analysis
Measured: From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up
Secondary outcomes (13)
Metabolic Outcome 1: Serum Calcium (mg/dL)
postoperative calcium levels. Below, Above or in the normal range for the method. Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
Measured: 1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 2 : Serum Phosphorus (mg/dL)
postoperative phosphorus levels. Below, above or the normal range for the method employed. Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
Measured: 1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)
postoperative alkaline phosphatase levels. Above or in the normal range, according to the method in use. Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
Measured: 1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 4: Serum Parathormone (pg/mL)
postoperative parathormone levels. Below, Above or in the target levels proposed by the National Kidney Foundation, and by the Kidney Disease Improving Global Outcomes (KDIGO). Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
Measured: 1 to 60 months after intervention, Samples are taken according to regular follow up
Drug Requirement 1: Elemental Calcium Intake (g/day)
The calcium supplement intake (in grams of elemental calcium per day) of the patients after the intervention. Analysis will include first week, then 1, 3, 6, 12, 24,36, 48, 60 months after the intervention.
Measured: 1 to 60 months after intervention, according to the dose prescibed in different periods.
Drug Requirement 2 Calcitriol intake (micrograms/day)
calcitriol or other vitamin D analogue intake (in micrograms per day) after the intervention. Analysis will include first week, then 1, 3, 6, 12, 24,36, 48, 60 months after the intervention.
Measured: 1 to 60 months after intervention, according to the dose prescibed in different periods
Drug Requirement 3: Sevelamer (mg/day)
The quantity of phosphorus binding drugs, in special Sevelamer prescribed in milligrams after the intervention. Analysis will include 1, 3, 6, 12, 24,36, 48, 60 months after the operation.
Measured: 1 to 60 months after intervention, according to the dose prescibed in different periods
Drug Requirement 4: Calcimimetics (mg/day)
The amount of Calcimimetics, in special Cinacalcet im milligrams per day prescribed after the intervention. Analysis will include 1, 3, 6, 12, 24,36, 48, 60 months after the intervention.
Measured: 1 to 60 months after intervention, according to the dose prescibed in different periods
Clinical Outcome 1: Bone Pain in the VAS
Bone pain measured by the Visual Analogic Pain Scale up to one week before the intervention and up to one week after the procedure, and then at regular follow up. Analysis will concentrate on preoperative (up to one week before), postoperative up to one week, 6,12, 24, 36, 48 and 60 months after the intervention.
Measured: Pre-operative (up to one week before the procedure) until 60 months after intervention
Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)
skeletal disease is defined as the occurrence of a fracture or the developement brown tumor (osteoclastomas) after the intervention, detected clinically or by any clinically oriented radiography ordered by the attending physician in routine follow up or in any emergency setting.
Measured: 1 to 60 months after intervention
Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire
quality of life up to one week before the intervention and after the operation at one week, 6 , 12, 24, 36, 48 and 60 months, measured by the Short form 36 questionnaire (SF-36) validated to the cultural and language of the country.
Measured: Preoperative (up to three days before the intervention) and until 60 months after intervention
Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)
the necessity of reoperative procedures due to recurrence or persistence of severe hyperparathyroidism, as defined by the attending physician during regular follow up
Measured: 1 to 60 months after intervention
Morbidity of the surgical procedures
After any interventions (initial operation or reoperative interventions necessary in the follow up), it will be actively searched for the occurrence of dysphonia (and its cause according to laryngoscopy), wound infection (clinical signs as red skin, pain, secretion, fever and laboratory evidence), and neck haematoma (large neck blood clots requiring operation)
Measured: intra-operative to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2012
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Arap, University of Sao Paulo General Hospital
- Investigators
- Sergio S Arap, M.D., Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464072
- Sponsor's protocol ID
- CAAE 00828412.8.0000.0068
- Status last verified
- May 2023
- First submitted
- 18 May 2015
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Filho WA, van der Plas WY, Brescia MDG, Nascimento CP Jr, Goldenstein PT, Neto LMM, Arap SS, Custodio MR, Bueno RO, Moyses RMA, Jorgetti V, Kruijf S, Montenegro FLM. Quality of life after surgery in secondary hyperparathyroidism, comparing subtotal parathyroidectomy with total parathyroidectomy with immediate parathyroid autograft: Prospective randomized trial. Surgery. 2018 Nov;164(5):978-985. doi: 10.1016/j.surg.2018.06.032. Epub 2018 Aug 3.
PubMed 30082137Albuquerque RFC, Carbonara CEM, Martin RCT, Dos Reis LM, do Nascimento CP Junior, Arap SS, Moyses RMA, Jorgetti V, Montenegro FLM, de Oliveira RB. Parathyroidectomy in patients with chronic kidney disease: Impacts of different techniques on the biochemical and clinical evolution of secondary hyperparathyroidism. Surgery. 2018 Feb;163(2):381-387. doi: 10.1016/j.surg.2017.09.005. Epub 2017 Nov 13.
PubMed 29146232Silveira AA, Brescia MDG, do Nascimento CP Jr, Arap SS, Montenegro FLM. Critical analysis of the intraoperative parathyroid hormone decrease during parathyroidectomy for secondary and tertiary hyperparathyroidism. Surgery. 2020 Dec;168(6):1079-1085. doi: 10.1016/j.surg.2020.06.043. Epub 2020 Aug 15.
PubMed 32811697Pereira GMD, Liao M, Arap SS, Magnabosco FF, Brescia MDG, Moyses RMA, Custodio MR, Jorgetti V, Kowalski LP, Montenegro FLM. Parathyroidectomy reduces the costs of medication in patients with secondary hyperparathyroidism. Clinics (Sao Paulo). 2024 Sep 15;79:100484. doi: 10.1016/j.clinsp.2024.100484. eCollection 2024.
PubMed 39284277Silveira AA, Brescia MDG, Nascimento CPD Jr, Arap SS, Montenegro FLM. Delayed sampling of intraoperative parathormone may be unnecessary during parathyroidectomy in kidney-transplanted and dialysis patients. J Bras Nefrol. 2021 Apr-Jun;43(2):228-235. doi: 10.1590/2175-8239-JBN-2020-0108.
PubMed 33475675
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Subtotal Parathyroidectomy or Total Parathyroidectomy With Immediate Heterotopic Autograft in Chronic Renal Disease Patients Stage V Under Dialysis
- ClinicalTrials.gov ID
- NCT02464072
- Acronym / sponsor ID
- CAAE 00828412.8.0000.0068
- Conditions
- Hyperparathyroidism, Secondary
- Keywords
- Parathyroidectomy, Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 8 Jun 2015 (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.
This study evaluates the metabolic and clinical results of two well recognized and accepted surgical techniques in the management of severe hyperparathyroidism in patients under regular dialysis treatment.
Detailed description
Prospective randomized trial in the surgical management of severe hyperparathyroidism of chronic kidney disease stage V under dialysis. Patients will be randomized and they will be submitted to subtotal parathyroidectomy or total parathyroidectomy with immediate heterotopic autograft of 45 or 90 fragments of parathyroid tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subtotal Parathyroidectomy | Experimental | Procedure: Subtotal ParathyroidectomyPatients will be submitted to subtotal parathyroidectomy. The intention is to leave a parathyroid remanent equivalent to two normal parathyroid glands in situ. The type of the operation is the intervention. No drugs or devices are tested. |
| Total Parathyroidectomy + 45 autografts | Active comparator | Procedure: Total Parathyroidectomy + 45 autograftsPatients will be submitted to a total parathyroidectomy and 45 fragments of parathyroid tissue are grafted in the forearm. This is the current standard treatment at the institution for severe secondary hyperparathyroidism.The type of operation is the intervention itself. No new device or drug is involved. |
| Total Parathyroidectomy + 90 autografts | Experimental | Procedure: Total Parathyroidectomy + 90 autograftsPatients will be submitted to a total parathyroidectomy and 90 fragments of parathyroid tissue are grafted in the forearm. The type of operation is the intervention. No new device or drug is involved. . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Stage V Chronic Kidney Disease patients under regular dialysis treatment with severe hyperparathyroidism requiring parathyroidectomy
Key exclusion criteria (5 listed)
- patients refusing to participate in the study (they will receive standard surgery),
- patients unable to attend regular follow up consultations,
- patients with a successful kidney transplant at the moment of parathyroidectomy,
- patients submitted to any previous surgery of the thyroid or parathyroid,
- patients with chronic kidney disease but not under dialysis
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 |
|---|---|---|
| Subtotal ParathyroidectomySubtotal parathyroid resection leaving the estimated mass of two normal parathyroid glands in situ. The type of operation is the intervention. No new device or drug is involved. | Procedure or surgery | Subtotal Parathyroidectomy |
| Total Parathyroidectomy + 45 autograftsImmediate autograft of 45 fragments of parathyroid tissue, after a total parathyroidectomy.This type of operation is the standard intervention at the institution at the moment. No new device or drug is involved. | Procedure or surgery | Total Parathyroidectomy + 45 autografts |
| Total Parathyroidectomy + 90 autograftsImmediate autograft of 90 fragments of parathyroid tissue, after a total parathyroidectomy.The type of operation is the intervention. No new device or drug is involved. | Procedure or surgery | Total Parathyroidectomy + 90 autografts |
Primary outcome
Survival
Time frame: From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up
Five years survival after parathyroidectomy in an intention to treat analysis
13 secondary outcomes
Metabolic Outcome 1: Serum Calcium (mg/dL)
Time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 2 : Serum Phosphorus (mg/dL)
Time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)
Time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 4: Serum Parathormone (pg/mL)
Time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
Drug Requirement 1: Elemental Calcium Intake (g/day)
Time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods.
Drug Requirement 2 Calcitriol intake (micrograms/day)
Time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods
Drug Requirement 3: Sevelamer (mg/day)
Time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods
Drug Requirement 4: Calcimimetics (mg/day)
Time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods
Clinical Outcome 1: Bone Pain in the VAS
Time frame: Pre-operative (up to one week before the procedure) until 60 months after intervention
Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)
Time frame: 1 to 60 months after intervention
Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire
Time frame: Preoperative (up to three days before the intervention) and until 60 months after intervention
Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)
Time frame: 1 to 60 months after intervention
Morbidity of the surgical procedures
Time frame: intra-operative to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 30082137Filho WA, van der Plas WY, Brescia MDG, Nascimento CP Jr, Goldenstein PT, Neto LMM, Arap SS, Custodio MR, Bueno RO, Moyses RMA, Jorgetti V, Kruijf S, Montenegro FLM. Quality of life after surgery in secondary hyperparathyroidism, comparing subtotal parathyroidectomy with total parathyroidectomy with immediate parathyroid autograft: Prospective randomized trial. Surgery. 2018 Nov;164(5):978-985. doi: 10.1016/j.surg.2018.06.032. Epub 2018 Aug 3.
- Background: PubMed 29146232Albuquerque RFC, Carbonara CEM, Martin RCT, Dos Reis LM, do Nascimento CP Junior, Arap SS, Moyses RMA, Jorgetti V, Montenegro FLM, de Oliveira RB. Parathyroidectomy in patients with chronic kidney disease: Impacts of different techniques on the biochemical and clinical evolution of secondary hyperparathyroidism. Surgery. 2018 Feb;163(2):381-387. doi: 10.1016/j.surg.2017.09.005. Epub 2017 Nov 13.
- Background: PubMed 32811697Silveira AA, Brescia MDG, do Nascimento CP Jr, Arap SS, Montenegro FLM. Critical analysis of the intraoperative parathyroid hormone decrease during parathyroidectomy for secondary and tertiary hyperparathyroidism. Surgery. 2020 Dec;168(6):1079-1085. doi: 10.1016/j.surg.2020.06.043. Epub 2020 Aug 15.
- Derived from this study: PubMed 39284277Pereira GMD, Liao M, Arap SS, Magnabosco FF, Brescia MDG, Moyses RMA, Custodio MR, Jorgetti V, Kowalski LP, Montenegro FLM. Parathyroidectomy reduces the costs of medication in patients with secondary hyperparathyroidism. Clinics (Sao Paulo). 2024 Sep 15;79:100484. doi: 10.1016/j.clinsp.2024.100484. eCollection 2024.
- Derived from this study: PubMed 33475675Silveira AA, Brescia MDG, Nascimento CPD Jr, Arap SS, Montenegro FLM. Delayed sampling of intraoperative parathormone may be unnecessary during parathyroidectomy in kidney-transplanted and dialysis patients. J Bras Nefrol. 2021 Apr-Jun;43(2):228-235. doi: 10.1590/2175-8239-JBN-2020-0108.
- Individual participant dataSharing planned: No
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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.
Sergio S Arap, M.D. principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtotal Parathyroidectomy, Total Parathyroidectomy + 45 autografts and Total Parathyroidectomy + 90 autografts in people with Hyperparathyroidism, Secondary, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 5 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: status not confirmed, as of the sponsor's last update on 17 May 2023. 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 Brazil. 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?
Results are not available in the source record.
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?
Survival (time frame: From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up). 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 NCT02464072, which also lists 5 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 17 May 2023.