Preoperative Steroids in Autoimmune Thyroid Disease
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.
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.
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.