Parathyroidectomy in Endstage Renal Disease

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

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-01-31

Brief Summary

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To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.

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Detailed Description

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Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.

Conditions

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Endstage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Parathyroidectomy group versus natural disease control group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

surgical total parathyroidectomy with forearm autografting

Group Type EXPERIMENTAL

parathyroidectomy

Intervention Type PROCEDURE

total parathyroidectomy with forearm autografting

Interventions

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parathyroidectomy

total parathyroidectomy with forearm autografting

Intervention Type PROCEDURE

Other Intervention Names

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total parathyroidectomy with forearm autografting

Eligibility Criteria

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Inclusion Criteria

* Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 500pg/ml on two or more occasions.
* Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
* Patients who provide informed consent for the study.

Exclusion Criteria

* Patients with significant background valvular heart disease
* Patients who are unfit for general anaesthesia
* Patients with acute myocardial infarction within recent two months
* Patients with poor general condition
* Patients with plans for living related kidney transplant within 1 year
* Patients with previous history of parathyroidectomy
* Patients with calciphylaxis
* Patients with underlying active malignancy
* Patients with contraindication for MRI

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No