Clinical Trial: A Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Relapsed Graves' Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Relapsed Graves' Disease

Brief Summary: To evaluate the short-term efficiency and safety of HIFU treatment in the relapsed Graves' disease.

Detailed Summary:

Grave's disease is the most common cause of hyperthyroidism and affects approximately 2% of women and 0.2% of men in the population. The use of antithyroid drugs (ATD) has been the first-line of treatment for Graves' disease in many centers for decades, and its use has been increasing worldwide. One reason for this is that it may induce remission, whereas radioiodine (RAI) and surgery often lead to hypothyroidism and other complications in addition to hospitalization and radiation exposure. However, ATD use is also associated with increasing risk of some adverse minor effects such as skin rash, gastric intolerance, and arthralgia in 5% of patients. Furthermore, major adverse events, such as agranulocytosis and hepatotoxicity may be life-threatening but are rare (<0.5% of cases). These usually occur during the first three to six months of treatment, and tend to be associated with high ATD doses. Therefore, the recommended duration of ATD treatment is generally not longer than 12-24 months. However, despite adequate medical treatment, up to 50-70% of patients with Graves' disease would relapse or recur and therefore, a more definitive approach using RAI treatment or thyroid surgery is eventually needed for the resolution of hyperthyroidism. Although RAI is considered safe and easy to manage, particularly in patients without Grave's ophthalmopathy (GO), subclinical and overt hypothyroidism may occur months or even years after the administration of RAI. Hence, long-term follow-up of thyroid function and GO as well as management of thyroxine replacement is necessary. Similarly, although surgery is the main therapeutic strategy, it carries a 2%-10% risk of complications such as hypocalcemia, transient or permanent recurrent laryngeal nerve palsy, bleeding, or postoperative infection. In view of these, various nonsurgical, minimally invasive treatment alternatives have been developed at specialized treatment centers.

Sponsor: The University of Hong Kong

Current Primary Outcome: Remission rate of Graves' disease after one successful course of HIFU [ Time Frame: 6 months ]

To evaluate the remission rate of relapsed Graves' disease after 6 months of HIFU treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The pain assessment (scoring 1-10) after treatment [ Time Frame: 6 months ]
    Patient pain score immediately after HIFU treatment.
  • Incidence of local or general adverse events [ Time Frame: 6 months ]
    The incidence rate of local or general adverse events after completion of HIFU treatment session.


Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: February 14, 2016
Date Started: October 2015
Date Completion:
Last Updated: November 9, 2016
Last Verified: November 2016