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

NCT ID: NCT01640184

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-11-30

Brief Summary

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.

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,.

Conditions

Hyperparathyroidism; Disorders of Parathyroid Gland

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active vitamin D

Intervention Type: DRUG

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.

Ultrasonic ablation

Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.

Group Type: EXPERIMENTAL

Ultrasonic ablation

Intervention Type: PROCEDURE

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.

Parathyroidectomy

Patients in parathyroidectomy group will be treated by parathyroid surgery.

Group Type: ACTIVE_COMPARATOR

Parathyroidectomy

Intervention Type: PROCEDURE

sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.

Interventions

Parathyroidectomy

sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

Parathyroid surgery; Oral medicine; Ultrasonic intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role: collaborator

Dongliang Zhang, MD

OTHER

Sponsor Role: lead

Responsible Party

Dongliang Zhang, MD

associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Linxue Qian, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Dongliang Zhang, Doctor

Role: STUDY_DIRECTOR

Beijing Friendship Hospital

Wenhu Liu, Doctor

Role: STUDY_CHAIR

Beijing Friendship Hospital

Locations

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Z121107001012138

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2001-2002-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012-079

Identifier Type: -

Identifier Source: org_study_id