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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Total thyroidectomy (Tx) versus thionamides (antithyroid drugs) in patients with moderate-to-severe Graves’ ophthalmopathy – a 1-year follow-up: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Lindsay Brammen, Philipp Riss, Julius Lukas, Alois Gessl, Daniela Dunkler, Shuren Li, Asha Leisser, Sandra Rezar-Dreindl, Katharina Eibenberger, Andreas Selberherr, Christian Scheuba, Andrea Papp
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2876-0) contains supplementary material, which is available to authorized users.

Abstract

Background

Graves’ disease (GD) is characterized by thyrotoxicosis and goiter and arises through circulating autoantibodies that bind to, and stimulate, the thyroid hormone receptor (TSHR). A temporal relation between the onset of hyperthyroidism and the onset of ophthalmopathy, a common extrathyroidal manifestation, has been demonstrated. Graves’ ophthalmopathy (GO) is typically characterized by an inflammation and expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered for hyperthyroidism caused by Graves’ disease: antithyroid drugs (ATD) (thionamides), radioiodine ablation (RAI) and thyroidectomy (Tx). To date, there is no clear recommendation on the treatment of Graves’ disease and GO, mainly due to the individuality of the disease in each patient. The aim of the study is 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/Design

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: Clinical Activity Score (CAScore), NOSPECS score, superonasal index measurements via ultrasound, and quality of life score.

Discussion

This study should allow for better therapeutic choices in patients with moderate-to-severe GO. In addition, it should demonstrate whether the outcome of GO in patients with moderate-to-severe GO is better in those who receive early Tx versus further ATD. Furthermore, this study will aim to establish a standard glucocorticoid scheme before and after Tx in patients with moderate-to-severe EO.

Trial registration

Eudra-CT: 2015–003515-38; Medical University of Vienna Protocol Record 1839/2015.
Date of Ethics Committee approval: 19 January 2017.
Registered on 27 January 2017.
Zusatzmaterial
Additional file 1: Quality of life questionnaire in German. (DOCX 18 kb)
13063_2018_2876_MOESM1_ESM.docx
Additional file 2: Case report form. (DOCX 72 kb)
13063_2018_2876_MOESM2_ESM.docx
Additional file 3: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: recommended items to address in clinical trial protocol and related documents*. (PDF 1664 kb)
13063_2018_2876_MOESM3_ESM.pdf
Literatur
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