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Subtotal Parathyroidectomy or Total Parathyroidectomy With Autograft in Chronic Kidney Disease Patients Under Dialysis

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ClinicalTrials.gov Identifier: NCT02464072
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sergio Arap, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Secondary Procedure: Subtotal Parathyroidectomy Procedure: Total Parathyroidectomy + 45 autografts Procedure: Total Parathyroidectomy + 90 autografts Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Subtotal Parathyroidectomy or Total Parathyroidectomy With Immediate Heterotopic Autograft in Chronic Renal Disease Patients Stage V Under Dialysis
Study Start Date : July 2012
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Subtotal Parathyroidectomy
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.
Procedure: Subtotal 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.

Active Comparator: Total Parathyroidectomy + 45 autografts
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.
Procedure: Total 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.

Experimental: Total Parathyroidectomy + 90 autografts
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. .
Procedure: Total 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Metabolic Outcome 1: Serum Calcium (mg/dL) [ Time Frame: 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.

  2. Metabolic Outcome 2 : Serum Phosphorus (mg/dL) [ Time Frame: 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.

  3. Metabolic Outcome 3: Serum Alkaline Phosphatase (IU) [ Time Frame: 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.

  4. Metabolic Outcome 4: Serum Parathormone (pg/mL) [ Time Frame: 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.

  5. Drug Requirement 1: Elemental Calcium Intake (g/day) [ Time Frame: 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.

  6. Drug Requirement 2 Calcitriol intake (micrograms/day) [ Time Frame: 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.

  7. Drug Requirement 3: Sevelamer (mg/day) [ Time Frame: 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.

  8. Drug Requirement 4: Calcimimetics (mg/day) [ Time Frame: 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.

  9. Clinical Outcome 1: Bone Pain in the VAS [ Time Frame: 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.

  10. Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor) [ Time Frame: 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.

  11. 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 ]
    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.

  12. Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease) [ Time Frame: 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

  13. Morbidity of the surgical procedures [ Time Frame: 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464072


Locations
Brazil
University of Sao Paulo General Hospital
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Sergio S Arap, M.D. University of Sao Paulo General Hospital

Responsible Party: Sergio Arap, Attending Physcian, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02464072     History of Changes
Other Study ID Numbers: CAAE 00828412.8.0000.0068
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sergio Arap, University of Sao Paulo General Hospital:
Parathyroidectomy
Renal Insufficiency, Chronic

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases