Preoperative Corticosteroids in Autoimmune Thyroid Disease

Phase 4

Recruiting

• Conditions: Graves Disease; Hashimoto Disease
• Interventions: Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT05435547
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Study Start: 2023-06-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroids	Dexamethasone	Will be given pre-operative corticosteroid regimen
placebo	Placebo	Will be given Placebo

Primary Outcome Measures

Name	Time	Method
Thyroid difficulty Scale score	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 Outcome Measures

Name	Time	Method
Surgical complication of transient hypoparathyroidism	Two weeks post-operative and six weeks post-operative	Number of subjects with Post-op PTH \<10
Surgical complication of permanent hypoparathyroidism	through study completion, or 6 months	Number of subjects with Post-op PTH \<10
Change in SF-20 at 6 months	through study completion, an average of 6 months	score ranges from 0 to 100, higher scores indicate better functioning or quality of life
Tg	through study completion, an average of 6 months	Tg, 1.3-31.8 ng/mL;
TgAB	through study completion, an average of 6 months	TgAB, 0-4.0 IU/mL;
TPO	through study completion, an average of 6 months	TPO AB 0-9.0 IU/mL;
TSI	through study completion, an average of 6 months	TSI 0-0.54 IU/L;
TRAb	through study completion, an average of 6 months	TRAb 0-1.75 IU/L
ThyPRO	through study completion, an average of 6 months	0 points (best outcome) - 340 points (worst outcome)
Change in blood flow / vascularity	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.
Surgical complication of transient hypocalcemia	Two weeks post-operative and six weeks post-operative	Number of subjects with transient hypocalcemia (calcium \<8.5)
Surgical complication of permanent hypocalcemia	through study completion, or 6 months	Number of subjects with permanent hypocalcemia (calcium \<8.5)
Surgical complication of recurrent laryngeal nerve palsy	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
Change in SF-20 at 6 weeks	Six weeks post-operative	score ranges from 0 to 100, higher scores indicate better functioning or quality of life

Trial Locations

Locations (3)

IU Health North Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States