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

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04080505

Collaborator

(none)

Enrollment

Location

Arms

93.7

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Graves Disease	Drug: SSKI- Potassium Iodide	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 10, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SSKI (Potassium Iodide) Participants randomized to receive 7 days of pre-operative SSKI	Drug: SSKI- Potassium Iodide 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

Arm

Intervention/Treatment

Active Comparator: SSKI (Potassium Iodide)

Participants randomized to receive 7 days of pre-operative SSKI

Drug: SSKI- Potassium Iodide

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

Outcome Measures

Primary Outcome Measures

Change in Vascular Flow from Baseline [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

no Graves' disease
< 18 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator: Jennifer Kuo, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Kuo, Assistant Professor of Surgery, Columbia University

ClinicalTrials.gov Identifier:

NCT04080505

Other Study ID Numbers:

AAAO3312

First Posted:

Sep 6, 2019

Last Update Posted:

Nov 11, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Graves Disease

Study Results

No Results Posted as of Nov 11, 2021