Hyperparathyroidism, Secondary
Conditions
Keywords
Parathyroidectomy, Renal Insufficiency, Chronic
Brief 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.
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.
Interventions
PROCEDURESubtotal Parathyroidectomy
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.
PROCEDURETotal Parathyroidectomy + 45 autografts
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.
PROCEDURETotal Parathyroidectomy + 90 autografts
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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Stage V Chronic Kidney Disease patients under regular dialysis treatment with severe hyperparathyroidism requiring parathyroidectomy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Outcome 2 : Serum Phosphorus (mg/dL) | 1 to 60 months after intervention, Samples are taken according to regular follow up | 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. |
| Metabolic Outcome 3: Serum Alkaline Phosphatase (IU) | 1 to 60 months after intervention, Samples are taken according to regular follow up | 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. |
| Metabolic Outcome 4: Serum Parathormone (pg/mL) | 1 to 60 months after intervention, Samples are taken according to regular follow up | 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. |
| Drug Requirement 1: Elemental Calcium Intake (g/day) | 1 to 60 months after intervention, according to the dose prescibed in different periods. | 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. |
| Drug Requirement 2 Calcitriol intake (micrograms/day) | 1 to 60 months after intervention, according to the dose prescibed in different periods | 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. |
| Drug Requirement 3: Sevelamer (mg/day) | 1 to 60 months after intervention, according to the dose prescibed in different periods | 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. |
| Metabolic Outcome 1: Serum Calcium (mg/dL) | 1 to 60 months after intervention, Samples are taken according to regular follow up | 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. |
| Clinical Outcome 1: Bone Pain in the VAS | Pre-operative (up to one week before the procedure) until 60 months after intervention | 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. |
| Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor) | 1 to 60 months after intervention | 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. |
| Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire | Preoperative (up to three days before the intervention) and until 60 months after intervention | 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. |
| Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease) | 1 to 60 months after intervention | the necessity of reoperative procedures due to recurrence or persistence of severe hyperparathyroidism, as defined by the attending physician during regular follow up |
| Morbidity of the surgical procedures | intra-operative to 60 months | 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) |
| Drug Requirement 4: Calcimimetics (mg/day) | 1 to 60 months after intervention, according to the dose prescibed in different periods | 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. |
Countries
Brazil
Outcome results
None listed