NCT01640184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed
Last Updated

October 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.3 years

First QC Date

July 9, 2012

Results QC Date

October 21, 2015

Last Update Submit

August 23, 2016

Conditions

HyperparathyroidismDisorders of Parathyroid Gland

Keywords

hyperparathyroidismvitamin Dultrasonic ablationsurgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (5)

  • Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).

    12 months

  • Changes of the Blood Levels on Calcium During 12 Months.

    Baseline and 12 months

  • Changes of Blood Levels on Phosphorus During 12 Months.

    Baseline and 12 months

  • Changes of Blood Levels on iPTH During 12 Months.

    Baseline and 12 months

  • Changes of Blood Levels on Bone Specific Alkaline Phosphatase.

    Baseline and 12 months

Study Arms (3)

Active vitamin D

ACTIVE COMPARATOR

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

Ultrasonic ablation

EXPERIMENTAL

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

Procedure: Ultrasonic ablation

Parathyroidectomy

ACTIVE COMPARATOR

Patients in parathyroidectomy group will be treated by parathyroid surgery.

Procedure: Parathyroidectomy

Interventions

ParathyroidectomyPROCEDURE

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

Also known as: Parathyroid surgery
Parathyroidectomy
Active vitamin DDRUG

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.

Also known as: Oral medicine
Active vitamin D
Ultrasonic ablationPROCEDURE

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.

Also known as: Ultrasonic intervention
Ultrasonic ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

HyperparathyroidismParathyroid Diseases

Interventions

ParathyroidectomyOral Medicine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, OperativeDentistry

Results Point of Contact

Title
Dr. Zhang Dongliang
Organization
Peking University International Hospital
zhangdongliang@pkuih.edu.cn
+86-10-69006561

Study Officials

  • Linxue Qian, Doctor

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

  • Dongliang Zhang, Doctor

    Beijing Friendship Hospital

    STUDY DIRECTOR

  • Wenhu Liu, Doctor

    Beijing Friendship Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 13, 2012

Study Start

August 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

October 17, 2016

Results First Posted

November 20, 2015

Record last verified: 2016-08

Locations

CN(2)