Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?

Graves Disease Clinical Trial

Official title:

Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080505
• Other study ID #: AAAO3312
• Status: Completed
• Phase: Phase 3
• Start date: February 10, 2015
• Est. completion date: March 3, 2023

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.

Exclusion Criteria:

• no Graves' disease

• < 18 years old

Related Conditions & MeSH terms

• Graves Disease

Intervention

Drug:
• SSKI- Potassium Iodide
1g/mL, 2 drops orally 3 times a day for 7 days before surgery

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline to Immediately Before Surgery