Preoperative Steroids in Autoimmune Thyroid Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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:
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Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on:
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Difficulty of surgery and rates of surgical complications
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Serum autoantibody levels
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Steroids Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care |
Drug: Prednisone
used to reduce inflammation
Other Names:
|
| No Intervention: No Steroids Pre-operative Standard of Care |
Outcome Measures
Primary Outcome Measures
- Thyroid Difficulty Scale Score [up to 4 weeks (Post Operative Day 1)]
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
- Change in Autoantibody Levels [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 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.
- Change in Antibody-mediated cytokine levels [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).
- Change in Short Form Health Survey (SF-12) Score [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 scored on a scale of 0-100, with higher numbers indicating higher quality of life.
- Change in Thyroid-specific quality of life patient-reported outcome measure for benign thyroid disorders (ThyPRO) Score [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 scored on a scale of 0-100 with higher scores indicating worse quality of life.
Secondary Outcome Measures
- Ultrasound doppler quantification of blood flow [baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1)]
- Surgical Complications: Parathyroid Hormone (PTH) Level [baseline (2-4 weeks prior to surgery), up to 6 weeks (2 weeks post-op)]
- Surgical Complications: Incidence of Recurrent Laryngeal Nerve (RLN) Injury [up to 4 weeks (Post Operative Day 1)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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]).
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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:
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Pediatric patients < 18
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Prior treatment with radioactive iodine (RAI)
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Known diagnosis of thyroid cancer
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Diabetic patients.
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Patients on any immunosuppressive regiment (such as organ transplant patients or patients treated for other autoimmune condition)
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Pregnant patients.
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Patients being treated for active infection.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Dawn K Elfenbein, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-0209
- Protocol Ver October 2020
- A539711
- SMPH/SURGERY/ENDOCRINE