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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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

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Hyperparathyroidism, Secondary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Subtotal Parathyroidectomy

Intervention Type PROCEDURE

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 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.

Group Type ACTIVE_COMPARATOR

Total Parathyroidectomy + 45 autografts

Intervention Type PROCEDURE

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 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. .

Group Type EXPERIMENTAL

Total Parathyroidectomy + 90 autografts

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No