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

University of Sao Paulo General Hospital

Status: Active, not recruiting

Conditions: Hyperparathyroidism, Secondary

Treatments: Procedure: Total Parathyroidectomy + 90 autografts; Procedure: Total Parathyroidectomy + 45 autografts; Procedure: Subtotal Parathyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02464072

CAAE 00828412.8.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 3 patient groups

Subtotal Parathyroidectomy

Experimental group

Description:

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.

Treatment:

Procedure: Subtotal Parathyroidectomy

Total Parathyroidectomy + 45 autografts

Active Comparator group

Description:

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.

Treatment:

Procedure: Total Parathyroidectomy + 45 autografts

Total Parathyroidectomy + 90 autografts

Experimental group

Description:

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. .

Treatment:

Procedure: Total Parathyroidectomy + 90 autografts