search
Back to results

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

Primary Purpose

Hyperparathyroidism, Disorders of Parathyroid Gland

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Parathyroidectomy
Active vitamin D
Ultrasonic ablation
Sponsored by
Dongliang Zhang, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism focused on measuring hyperparathyroidism, vitamin D, ultrasonic ablation, surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chao-Yang Hospital
  • Beijing Friendship Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Active vitamin D

Ultrasonic ablation

Parathyroidectomy

Arm Description

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.

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

Patients in parathyroidectomy group will be treated by parathyroid surgery.

Outcomes

Primary Outcome Measures

Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2012
Last Updated
August 23, 2016
Sponsor
Dongliang Zhang, MD
Collaborators
Beijing Municipal Science & Technology Commission
search

1. Study Identification

Unique Protocol Identification Number
NCT01640184
Brief Title
Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
Official Title
Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dongliang Zhang, MD
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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,.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Disorders of Parathyroid Gland
Keywords
hyperparathyroidism, vitamin D, ultrasonic ablation, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active vitamin D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasonic ablation
Arm Type
Experimental
Arm Description
Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Arm Title
Parathyroidectomy
Arm Type
Active Comparator
Arm Description
Patients in parathyroidectomy group will be treated by parathyroid surgery.
Intervention Type
Procedure
Intervention Name(s)
Parathyroidectomy
Other Intervention Name(s)
Parathyroid surgery
Intervention Description
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
Drug
Intervention Name(s)
Active vitamin D
Other Intervention Name(s)
Oral medicine
Intervention Description
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
Procedure
Intervention Name(s)
Ultrasonic ablation
Other Intervention Name(s)
Ultrasonic intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).
Description
Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
Time Frame
12 months
Title
Changes of the Blood Levels on Calcium During 12 Months.
Description
The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
Time Frame
Baseline and 12 months
Title
Changes of Blood Levels on Phosphorus During 12 Months.
Description
The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
Time Frame
Baseline and 12 months
Title
Changes of Blood Levels on iPTH During 12 Months.
Description
The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
Time Frame
Baseline and 12 months
Title
Changes of Blood Levels on Bone Specific Alkaline Phosphatase.
Description
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.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linxue Qian, Doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongliang Zhang, Doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wenhu Liu, Doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs