Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
Primary Purpose
Graves Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SSKI- Potassium Iodide
Sponsored by
About this trial
This is an interventional other trial for Graves Disease
Eligibility Criteria
Inclusion Criteria:
- individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.
Exclusion Criteria:
- no Graves' disease
- < 18 years old
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
SSKI (Potassium Iodide)
NO SSKI
Arm Description
Participants randomized to receive 7 days of pre-operative SSKI
Participants randomized to not receive any drug pre-operative
Outcomes
Primary Outcome Measures
Change in Vascular Flow from Baseline
Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04080505
Brief Title
Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
Official Title
Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2015 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to find out if SSKI (Potassium Iodide) reduces vascularity (the number and concentration of blood vessels) and improves how well patients do after surgery for removal of their whole thyroid gland in Graves' disease (an autoimmune disease that is a common cause of hyperthyroidism).
Detailed Description
Patients with Graves' disease and goiters tend to have very vascular thyroid glands, which increases operative bleeding risks/rates. Many surgeons treat these patients with preoperative SSKI which is believed to decrease the vascularity, which in turn may decrease bleeding risks. However, there has been no quantitative data published on whether this is a real effect with true clinical benefit, in either animal or human models with SSKI. There have been some studies in Europe studying Lugol's solution, a different formulation of iodine, which show some decreased vascularity using color Doppler or measurements of CD34 cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
All participants complete a baseline neck ultrasound no less than 7 days prior to surgery, to obtain vascular flow imaging. Participants are then randomized to receive 7 days of pre-operative SSKI or not receive any drug. In the practice at Columbia, all patients with Graves' disease receive SSKI preoperatively, though this is not standard practice across the country, thus the 'no drug' group is experimental for research.
All participants complete a second ultrasound on the operating table before surgery, to assess for change in vascularity (experimental, as not all patients receive intra-operative ultrasounds before surgery). Both ultrasounds are performed by the surgeon.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSKI (Potassium Iodide)
Arm Type
Active Comparator
Arm Description
Participants randomized to receive 7 days of pre-operative SSKI
Arm Title
NO SSKI
Arm Type
No Intervention
Arm Description
Participants randomized to not receive any drug pre-operative
Intervention Type
Drug
Intervention Name(s)
SSKI- Potassium Iodide
Intervention Description
1g/mL, 2 drops orally 3 times a day for 7 days before surgery
Primary Outcome Measure Information:
Title
Change in Vascular Flow from Baseline
Description
Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.
Time Frame
From Baseline to Immediately Before Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.
Exclusion Criteria:
no Graves' disease
< 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Kuo, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
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