Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy

Sponsor
Medical University of Vienna (Other)
Overall Status
Unknown status
CT.gov ID
NCT03066076
Collaborator
(none)
60
1
2
27
2.2

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
  • Drug: Antithyroid Drug
  • Procedure: Total thyroidectomy
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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
Observer blinded analysis
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) Versus Thionamides (Anti-Thyroid Drugs) in Patients With Moderate-to-Severe Graves' Ophthalmopathy - a 1-year Follow-up
Anticipated Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Feb 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Thyroidectomy

Total thyroidectomy

Drug: Antithyroid Drug
Antithyroid drug
Other Names:
  • Thiamazol
  • Propylthiouracil
  • Active Comparator: Antithyroid drug

    Thiamazol, Propylthiouracil

    Procedure: Total thyroidectomy
    Operation

    Outcome Measures

    Primary Outcome Measures

    1. Muscle index (MI) from ultrasound measurements [12 months]

      Muscle index (MI) from ultrasound measurements

    2. Thyroid antibodies [12 months]

      Thyroid antibodies

    Secondary Outcome Measures

    1. CAScore/NOSPECS score [12 months]

      CAScore/NOSPECS score

    2. Superonasal index measurements via ultrasound [12 months]

      Superonasal index measurements via ultrasound

    3. Quality of life score [12 months]

      Quality of life score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. GD and GO onset < 12 months

    2. no previous GD treatment other than antithyroid drugs (ATD)

    3. first relapse after decrease of antithyroid medication within 4-6 months

    4. GO treatment with glucocorticoids based on the Kahaly scheme

    5. patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO

    6. clinically active inflammation according to CAScore (>3/7)

    7. informed consent

    Exclusion Criteria:
    1. GD and GO onset > 12 months

    2. more than one relapse of GO longer than 6 months from diagnosis

    3. previous GD treatment by RAI or surgery

    4. SNI greater than 7.0

    5. urgent orbital decompression surgery

    6. loss of vision

    7. loss of visual field

    8. loss of color vision

    9. patients not receiving glucocorticoids for GO

    10. cytological findings of postsurgical histopathological results suspicious for malignancy

    11. pregnancy or breast-feeding

    12. contraindication to GC

    13. halt of GC therapy

    14. Patients with diabetes mellitus

    15. age below 18 years

    16. 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.
    Responsible Party:
    Philipp Riss, Professor, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT03066076
    Other Study ID Numbers:
    • 1839/2015
    • 2015-003515-38
    First Posted:
    Feb 28, 2017
    Last Update Posted:
    Feb 28, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2017