Trial Outcomes & Findings for Preoperative Steroids in Autoimmune Thyroid Disease (NCT NCT04542278)

NCT ID: NCT04542278

Last Updated: 2023-12-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: surgery occurs up to 4 weeks, data collected a conclusion of operation
• Results posted on: 2023-12-26

Participant Flow

Participant milestones

Measure	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 Prednisone: used to reduce inflammation	No Steroids Pre-operative Standard of Care
Overall Study STARTED	14	16
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care	Total n=30 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 14 • n=14 Participants	48 years STANDARD_DEVIATION 15 • n=16 Participants	44.0 years STANDARD_DEVIATION 14.7 • n=30 Participants
Sex: Female, Male Female	11 Participants n=14 Participants	14 Participants n=16 Participants	25 Participants n=30 Participants
Sex: Female, Male Male	3 Participants n=14 Participants	2 Participants n=16 Participants	5 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 participants n=14 Participants	16 participants n=16 Participants	30 participants n=30 Participants
Number of Participants with Body Mass Index greater than or equal to 35	2 Participants n=14 Participants	3 Participants n=16 Participants	5 Participants n=30 Participants
Body Mass Index	30 kg/m^2 STANDARD_DEVIATION 4 • n=14 Participants	32 kg/m^2 STANDARD_DEVIATION 10 • n=16 Participants	31.5 kg/m^2 STANDARD_DEVIATION 7.9 • n=30 Participants
Diagnosis Graves'	8 Participants n=14 Participants	9 Participants n=16 Participants	17 Participants n=30 Participants
Diagnosis Hashimoto's	6 Participants n=14 Participants	7 Participants n=16 Participants	13 Participants n=30 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care
Thyroid Difficulty Scale Score	9.8 score on a scale Standard Deviation 3.8	9.75 score on a scale Standard Deviation 4.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care
Percent Change From Baseline Mean in Autoantibody Levels surgery to 2 weeks post op	0.81 percent change from baseline mean Standard Deviation 0.8	0.78 percent change from baseline mean Standard Deviation 0.24
Percent Change From Baseline Mean in Autoantibody Levels surgery to 6 weeks post-op	0.43 percent change from baseline mean Standard Deviation 0.23	0.54 percent change from baseline mean Standard Deviation 0.28
Percent Change From Baseline Mean in Autoantibody Levels surgery to 6 months post-op	0.12 percent change from baseline mean Standard Deviation 0.04	0.24 percent change from baseline mean Standard Deviation 0.24

PRIMARY outcome

Timeframe: 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)

Population: Investigators did not collect cytokines, as originally planned, as they did not have the storage space or equipment they initially thought.

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care
Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) baseline	39.4 score on a scale Standard Deviation 11	35.3 score on a scale Standard Deviation 17.6
Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) 6 weeks post-op	46.7 score on a scale Standard Deviation 15.7	38.6 score on a scale Standard Deviation 19.3
Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) 6 months post-op	43.4 score on a scale Standard Deviation 16.4	40.3 score on a scale Standard Deviation 22.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care
Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) baseline	41.5 score on a scale Standard Deviation 10.4	43.2 score on a scale Standard Deviation 18.1
Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) 6 weeks post-op	47.4 score on a scale Standard Deviation 14.4	42.7 score on a scale Standard Deviation 20.9
Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) 6 months post-op	50.2 score on a scale Standard Deviation 15.8	44.2 score on a scale Standard Deviation 24.2

PRIMARY outcome

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

Population: Not all participants provided survey data for all time points.

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.

Outcome measures

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care
Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score Baseline	2.03 score on a scale Interval 1.17 to 3.25	1.95 score on a scale Interval 0.67 to 2.93
Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score 6 weeks post-op	1.47 score on a scale Interval 0.5 to 2.83	1.05 score on a scale Interval 0.36 to 2.14
Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score 6 months post-op	1.29 score on a scale Interval 0.33 to 2.89	0.99 score on a scale Interval 0.21 to 2.14

SECONDARY outcome

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

Population: Investigators were unable to come up with a system to quantify doppler flow, so data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care
Surgical Complications: Parathyroid Hormone (PTH) Level	52 pg/mL Standard Deviation 43	38 pg/mL Standard Deviation 30

SECONDARY outcome

Timeframe: up to 4 weeks (Post Operative Day 1)

Outcome measures

Measure	Steroids n=14 Participants 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 Prednisone: used to reduce inflammation	No Steroids n=16 Participants Pre-operative Standard of Care
Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury	2 Participants	2 Participants

Adverse Events

Steroids

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

No Steroids

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Steroids n=14 participants at risk 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 Prednisone: used to reduce inflammation	No Steroids n=16 participants at risk Pre-operative Standard of Care
Psychiatric disorders insomnia	42.9% 6/14 • up to 6 months post-operatively	0.00% 0/16 • up to 6 months post-operatively
Psychiatric disorders mood changes	28.6% 4/14 • up to 6 months post-operatively	0.00% 0/16 • up to 6 months post-operatively
Gastrointestinal disorders Gastrointestinal Upset	21.4% 3/14 • up to 6 months post-operatively	0.00% 0/16 • up to 6 months post-operatively
Gastrointestinal disorders increased appetite	14.3% 2/14 • up to 6 months post-operatively	0.00% 0/16 • up to 6 months post-operatively
Gastrointestinal disorders Nausea	14.3% 2/14 • up to 6 months post-operatively	0.00% 0/16 • up to 6 months post-operatively
Injury, poisoning and procedural complications Nerve Injury	0.00% 0/14 • up to 6 months post-operatively	6.2% 1/16 • up to 6 months post-operatively
Respiratory, thoracic and mediastinal disorders Shortness of Breath	7.1% 1/14 • up to 6 months post-operatively	0.00% 0/16 • up to 6 months post-operatively
Metabolism and nutrition disorders Hypocalcemia	7.1% 1/14 • up to 6 months post-operatively	6.2% 1/16 • up to 6 months post-operatively

Additional Information

Dawn Elfenbein, MD, MPH, FACS

University of Wisconsin - Madison School of Medicine and Public Health

Phone: (608) 263-1387

Email: elfenbein@surgery.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place