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NCT Number: NCT05435547

Preoperative Corticosteroids in Autoimmune Thyroid Disease

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.

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Key information

Conditions

Graves Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Hashimoto Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IU Health Methodist Hospital, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:

■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.

  • Exclusion Criteria:
  • Pediatric patients < 18
  • Prior treatment with RAI
  • Prior neck surgeries
  • Known diagnosis of thyroid cancer
  • Diabetic patients on medications
  • A history of adverse reactions to corticosteroids.
  • Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.

Treatment and study plan

Dexamethasone

Drug

Will take Dexamethasone pre-operatively

Placebo

Drug

Will take Placebo pre-operatively

Primary outcomes

  1. Thyroid difficulty Scale score

    Time frame: Day of Surgery

    This scale is completed by the surgeon to assess the difficulty of a thyroid operation, and includes 4 parameters (vascularity, friability, mobility/fibrosis, and gland size). The scale ranges from 4 points (best outcome) - 20 points (worst outcome). Higher scores indicate a more difficult operation.

Secondary outcomes

  1. Change in blood flow / vascularity

    Time frame: Pre-operative visit and Day of Surgery

    The surgeon will use ultrasound to assess the vascularity of the surgical area. Scoring is dependent on thyroid gland size, whether there is substernal extension, and the level of vascularity. The minimum score (2) indicates normal vascularity and normal gland size with no substernal extension. The maximum score (11) indicates extensive vascularity and large gland size with substernal extension.

  2. Surgical complication of transient hypocalcemia

    Time frame: Two weeks post-operative and six weeks post-operative

    Number of subjects with transient hypocalcemia (calcium <8.5)

  3. Surgical complication of permanent hypocalcemia

    Time frame: through study completion, or 6 months

    Number of subjects with permanent hypocalcemia (calcium <8.5)

  4. Surgical complication of transient hypoparathyroidism

    Time frame: Two weeks post-operative and six weeks post-operative

    Number of subjects with Post-op PTH <10

  5. Surgical complication of permanent hypoparathyroidism

    Time frame: through study completion, or 6 months

    Number of subjects with Post-op PTH <10

  6. Surgical complication of recurrent laryngeal nerve palsy

    Time frame: Two weeks post-operative and six-weeks post-operative, if clinically indicated

    Vocal cord dysfunction will be evaluated through voice assessment and/or flexible laryngoscopy

  7. Change in SF-20 at 6 weeks

    Time frame: Six weeks post-operative

    score ranges from 0 to 100, higher scores indicate better functioning or quality of life

  8. Change in SF-20 at 6 months

    Time frame: through study completion, an average of 6 months

    score ranges from 0 to 100, higher scores indicate better functioning or quality of life

  9. Tg

    Time frame: through study completion, an average of 6 months

    Tg, 1.3-31.8 ng/mL;

  10. TgAB

    Time frame: through study completion, an average of 6 months

    TgAB, 0-4.0 IU/mL;

  11. TPO

    Time frame: through study completion, an average of 6 months

    TPO AB 0-9.0 IU/mL;

  12. TSI

    Time frame: through study completion, an average of 6 months

    TSI 0-0.54 IU/L;

  13. TRAb

    Time frame: through study completion, an average of 6 months

    TRAb 0-1.75 IU/L

  14. ThyPRO

    Time frame: through study completion, an average of 6 months

    0 points (best outcome) - 340 points (worst outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandria McDow, MD

CONTACT

[email protected]

317-944-4377

Hannah Allison, MA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2022
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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