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Completed

NCT Number: NCT04542278

Preoperative Steroids in Autoimmune Thyroid Disease

This pilot project will randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult. It will enroll 30 participants who will each be on study for up to 7 months.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

Graves' disease and Hashimoto's thyroiditis are autoimmune conditions affecting the thyroid gland. Surgery to remove the thyroid gland in these patients may be complicated by the inflammatory nature of these diseases. Prednisone is a steroid medication used to decrease inflammation of the thyroid gland in other disease states such as sub-acute thyroiditis, but has not been used systematically to reduce inflammation in patients about to undergo surgery.

This is a pilot project that proposes to randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult. This could potentially lead to better outcomes for these patients, as well as increased time to recovery and improved quality of life.

This project proposes to administer short quality of life surveys at three time points, as well as draw additional labs to measure inflammation and antibody levels at times when patients will already be getting labs drawn for clinical purposes. The purpose of this study is to generate preliminary data from which a larger, blinded, placebo-controlled trial could be designed.

These specific aims are:

  • Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on:
  • Difficulty of surgery and rates of surgical complications
  • Serum autoantibody levels
  • Longitudinally assess the impact of surgical treatment on QoL in patients with autoimmune thyroid disease

Update: Protocol amendment approved on 10-22-2020: Study team decided to omit the aim 'antibody-mediated cytokine levels' from the protocol and consent process as it became cost-prohibitive for processing and storage fees. Cytokine levels are not something typically collected or tracked in the course of clinical care, and may not be relevant. Study can proceed without this aim and will not alter the main outcome measures of antibody levels and difficulty of the operation.

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 (Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]).
  • Participants will be invited to join the study after the decision has been made to proceed with thyroidectomy as the clinical treatment of their autoimmune thyroid disease.

Exclusion criteria

  • Pediatric patients < 18
  • Prior treatment with radioactive iodine (RAI)
  • Known diagnosis of thyroid cancer
  • Diabetic patients.
  • Patients on any immunosuppressive regiment (such as organ transplant patients or patients treated for other autoimmune condition)
  • Pregnant patients.
  • Patients being treated for active infection.
  • Any patient for whom the surgeon feels steroids would provide a clear benefit (ie. Extremely high auto-antibody levels with a very large, inflamed thyroid gland) will be treated according to the clinical judgement of the surgeon. If a surgeon feels steroids are indicated and prescribes them, the patient will not be eligible for the trial.

Treatment and study plan

Prednisone

Drug

used to reduce inflammation

Other names: steroid drug

Primary outcomes

  1. Thyroid Difficulty Scale Score

    Time frame: surgery occurs up to 4 weeks, data collected a conclusion of operation

    The surgeon will fill out the "Thyroid Difficulty Scale" at the conclusion of the operation. This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid. The total possible range of scores from 4-20, higher scores indicate increased difficulty in thyroid surgery

  2. Percent Change From Baseline Mean in Autoantibody Levels

    Time frame: baseline measure day of surgery (up to 4 weeks), up to 6 weeks (2 weeks post-op), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

    Autoantibodies that may be positive include: Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]. Any that were positive pre-op will be measured at each time point. Baseline level will be 1.

  3. Change in Antibody-mediated Cytokine Levels

    Time frame: baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1), up to 6 weeks (2 weeks post-op), up to 30 weeks (6 months post-op)

    Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex. Cytokines that have been implicated in other autoimmune disease include: IFN-gamma (BR29), IL-6 (BR13), IL-10 (BR22), IL-13 (BR47), IL-15 (BR63), IL-17A (BR42), and VEGF-C (BR38).

  4. Change in Short Form Health Survey (SF-12) Mental Component Score (MCS)

    Time frame: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

    The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life.

  5. Change in Short Form Health Survey (SF-12) Physical Component Score (PCS)

    Time frame: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

    The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life.

  6. Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score

    Time frame: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

    The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life. It is a 39-item survey that was scored from 0-4, higher scores indicate worse quality of life.

Secondary outcomes

  1. Ultrasound Doppler Quantification of Blood Flow

    Time frame: baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1)

  2. Surgical Complications: Parathyroid Hormone (PTH) Level

    Time frame: immediately after surgery (baseline for all participants)

    PTH is measured right after surgery to determine whether the nearby parathyroid glands were injured during surgery. Low PTH levels immediately after surgery are concerning for symptomatic low calcium levels, either temporarily or permanent, after thyroidectomy. Normal PTH is typically between 20-70.

  3. Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury

    Time frame: up to 4 weeks (Post Operative Day 1)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Randomized Controlled Trial of Preoperative Steroids in Autoimmune Thyroid Disease

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Dec 26, 2023

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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