Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2028-05-31

Brief Summary

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Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.

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Detailed Description

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The trial was performed as a nonconfirmatory randomized controlled pilot trial with 200 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 5-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 5-year follow-up.

Conditions

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Secondary Hyperparathyroidism;Parathyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Total Parathyroidectomy Alone

Total Parathyroidectomy Alone , without autotransplantation

Group Type EXPERIMENTAL

Parathyroidectomy

Intervention Type PROCEDURE

Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone

Total Parathyroidectomy With Autotransplantation

Group Type ACTIVE_COMPARATOR

Parathyroidectomy

Intervention Type PROCEDURE

Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone

Interventions

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Parathyroidectomy

Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Severe renal secondary hyperparathyroidism

Exclusion Criteria

Patients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No