Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy
Study Details
Study Description
Brief Summary
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Thyroidectomy Total thyroidectomy |
Drug: Antithyroid Drug
Antithyroid drug
Other Names:
|
Active Comparator: Antithyroid drug Thiamazol, Propylthiouracil |
Procedure: Total thyroidectomy
Operation
|
Outcome Measures
Primary Outcome Measures
- Muscle index (MI) from ultrasound measurements [12 months]
Muscle index (MI) from ultrasound measurements
- Thyroid antibodies [12 months]
Thyroid antibodies
Secondary Outcome Measures
- CAScore/NOSPECS score [12 months]
CAScore/NOSPECS score
- Superonasal index measurements via ultrasound [12 months]
Superonasal index measurements via ultrasound
- Quality of life score [12 months]
Quality of life score
Eligibility Criteria
Criteria
Inclusion Criteria:
-
GD and GO onset < 12 months
-
no previous GD treatment other than antithyroid drugs (ATD)
-
first relapse after decrease of antithyroid medication within 4-6 months
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GO treatment with glucocorticoids based on the Kahaly scheme
-
patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO
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clinically active inflammation according to CAScore (>3/7)
-
informed consent
Exclusion Criteria:
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GD and GO onset > 12 months
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more than one relapse of GO longer than 6 months from diagnosis
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previous GD treatment by RAI or surgery
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SNI greater than 7.0
-
urgent orbital decompression surgery
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loss of vision
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loss of visual field
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loss of color vision
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patients not receiving glucocorticoids for GO
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cytological findings of postsurgical histopathological results suspicious for malignancy
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pregnancy or breast-feeding
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contraindication to GC
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halt of GC therapy
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Patients with diabetes mellitus
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age below 18 years
-
no informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Surgery and Department of Ophthalmology Medical University Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Philipp Riss, MD, Medical University Vienna
- Principal Investigator: Guido Dorner, MD, Medical University Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1839/2015
- 2015-003515-38