Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients

August 23, 2016 updated by: Dongliang Zhang, MD

Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.

It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable alternative treatment that help control secondary hyperparathyroidism in CKD patients presenting with enlarged parathyroid gland(s) visible at ultrasonography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term dialysis treatments. sHPT is damaged for bone system, blood system, cardiovascular system, and so on. The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of medicines, and parathyroidectomy. In the mainland of China, there are not certain useful medicines to treat sHPT, including the derivatives of vitamin D, calcimimetic agent, non calcium aluminum phosphate binders. Furthermore, medical therapy is not always successful in achieving adequate control of sHPT. Oral medications have efficacy limitations as well as side-effects. Otherwise, surgery treatment can only be used for the patients with enlarged parathyroid gland(s). The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy.

Then ultrasonic ablation may become a valuable alternative treatment that help control sHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital
      • Beijing, Beijing, China, 100020
        • Beijing Chao-Yang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with age between 18 - 75 years.
  • Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
  • CKD patients in stage 5, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
  • CKD patients have been followed up more than 6 months.

Exclusion Criteria:

  • Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
  • Patient who underwent total parathyroidectomy and without enlarged parathyroid gland(s).
  • Known history of parathyroid or other neoplasias in the neck region.
  • History of neck irradiation.
  • Major surgery of neck in the last 3 months or other major surgery projected in the subsequent 4 months.
  • Pregnant or lactating woman.
  • Patient receiving drugs such as phenobarbital, phenytoin, rifampicin, sucralfate, steroids, flecainide, thioridazine, or most tricyclic antidepressants which could affect vitamin D metabolism.
  • Treatment with vitamin D derivatives, cinacalcet or other calcimimetics within the past 6 months.
  • Patients who are currently participating in another clinical trial.
  • The expected live time is less than 1 year.
  • Patients suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
  • Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active vitamin D
Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in Kidney Developement Improvement Global Outcomes (KDIGO) guidelines.
Drug: Active vitamin D
CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.
Other Names:
  • Oral medicine
EXPERIMENTAL: Ultrasonic ablation
Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Procedure: Ultrasonic ablation
CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.
Other Names:
  • Ultrasonic intervention
ACTIVE_COMPARATOR: Parathyroidectomy
Patients in parathyroidectomy group will be treated by parathyroid surgery.
Procedure: Parathyroidectomy
sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Other Names:
  • Parathyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
Time Frame: 12 months
The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).
Time Frame: 12 months
Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
12 months
Changes of the Blood Levels on Calcium During 12 Months.
Time Frame: Baseline and 12 months
The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
Baseline and 12 months
Changes of Blood Levels on Phosphorus During 12 Months.
Time Frame: Baseline and 12 months
The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
Baseline and 12 months
Changes of Blood Levels on iPTH During 12 Months.
Time Frame: Baseline and 12 months
The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
Baseline and 12 months
Changes of Blood Levels on Bone Specific Alkaline Phosphatase.
Time Frame: Baseline and 12 months
The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongliang Zhang, MD

Collaborators

Beijing Municipal Science & Technology Commission

Investigators

  • Study Director: Dongliang Zhang, Doctor, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (ESTIMATE)

July 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-079
  • Z121107001012138 (OTHER_GRANT: Beijing Municipal Science and Technology Commission)
  • 2001-2002-02 (OTHER_GRANT: The capital health research and development of special)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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