- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04080505
Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
April 11, 2023 updated by: Columbia University
Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?
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).
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Kuo, MD
- Phone Number: 212-305-6969
- Email: jhk2029@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.
Exclusion Criteria:
- no Graves' disease
- < 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SSKI (Potassium Iodide)
Participants randomized to receive 7 days of pre-operative SSKI
|
1g/mL, 2 drops orally 3 times a day for 7 days before surgery
|
No Intervention: NO SSKI
Participants randomized to not receive any drug pre-operative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vascular Flow from Baseline
Time Frame: From Baseline to Immediately Before Surgery
|
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.
|
From Baseline to Immediately Before Surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Kuo, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2015
Primary Completion (Actual)
March 3, 2023
Study Completion (Actual)
March 3, 2023
Study Registration Dates
First Submitted
September 4, 2019
First Submitted That Met QC Criteria
September 4, 2019
First Posted (Actual)
September 6, 2019
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAO3312
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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