The Efficacy and Safety of Microwave Ablation for Mild-to-moderate Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

NCT02332135 | Unknown DMC

• 1 other identifier: BJFH-EC/2014-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Microwave ablation, as a new method to therapy secondary hyperparathyroidism(SHPT), now is developing rapidly. However, it is still unknown whether it is effective to accept microwave ablation for hemodialysis patients with mild-to-moderate SHPT. In this prospective, randomised control and paried clinical trial study, the investigators will observe the efficiency and safety of microwave ablation in hemodialysis patients with mild-to-moderate secondary hyperparathyroidism. The patients in age-matched control group will accept active Vitamin D therapy.

Conditions

Secondary Hyperparathyroidism; Maintenance Hemodialysis

Keywords

microwave ablation; maintenance hemodialysis; mild-to-moderate Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (3)

• Overall rate of achieving target for iPTH during the study period.

  The blood level of intact iPTH will be detected every other month for stable patients.

  12 months

• The change of iPTH level after MWA.

  The blood level of intact iPTH will be detected every other month for stable

  12 months

• The rate of subjects developed into severe SHPT

  12 months

Secondary Outcomes (3)

• Calcitriol weekly dosage.

  12 months

• Overall rate of achieving target for serum calcium and phosphorus.

  12 months

• Changes of serum calcium and phosphorus after MWA.

  12 months

Study Arms (2)

microwave ablation group

EXPERIMENTAL

patients in ultrasonic ablation will be treated by ultrasound guided percutaneous parathyroid gland microwave ablation

Procedure: microwave ablation

control group

ACTIVE COMPARATOR

patients in control group will be treated by active vitamin D and other general treatments according to the suggestions in K/DOQI guidelines

Drug: active vitamin D

Interventions

microwave ablation PROCEDURE

First, the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are between 300pg/ml and 800pg/ml and who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan are chosen to involve in this study. Patients are divided into 2 groups at random, the control group and the microwave ablation group. In the microwave ablation group, patients will accept microwave ablation. Oral medicines, if needed, will be taken according to the the suggestions in K/DOQI guideline.

microwave ablation group

active vitamin D DRUG

The control group will be treated by active vitamin D and other general treatment,such as dietary phosphate restriction and phosphate binders,according to the suggestions in K/DOQI guideline.

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• patients in hemodialysis, whose iPTH is between 300pg/ml and 800pg/ml.

You may not qualify if:

• primary or tertiary hyperparathyroidism(hyperparathyroidism after kidney transplantation).
• patient who underwent total parathyroidectomy.
• Known history of parathyroid or other neoplasias in the neck region.
• History of neck trauma.
• major surgery of neck in the last 3 months or in next 4months.
• pregnant or lactating woman.
• patients with severe liver disease and abnormal blood clotting mechanism.
• patients with chronic wasting disease.
• patients who is taking glucocorticoids.
• patients who have other disorders affecting calcium and phosphorus metabolism.
• patients whose concurrent illnesses,disability,or geographical residence would hamper attendance at required study visit.

Sponsors & Collaborators

• Wenhu Liu: lead

Study Sites (1)

Beijing Friedship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Wenhu Liu, doctor

  Beijing Friendship Hospital

  STUDY CHAIR

• Zongli Diao, master

  Beijing Friendship Hospital

  STUDY DIRECTOR

• Linxue Qian, doctor

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zongli Diao, master

CONTACT

+86-01-63138579; diaoted@163.com

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: Professor

Study Record Dates

• First Submitted: January 4, 2015
• First Posted: January 6, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

CN (1)