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Low enrollment
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSKI (Potassium Iodide) | Active Comparator | Participants randomized to receive 7 days of pre-operative SSKI |
|
| NO SSKI | No Intervention | Participants randomized to not receive any drug pre-operative |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSKI- Potassium Iodide | Drug | 1g/mL, 2 drops orally 3 times a day for 7 days before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Kuo, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
2 participants withdrew from the study prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | SSKI (Potassium Iodide) | Participants randomized to receive 7 days of pre-operative SSKI SSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery |
| FG001 | No SSKI | Participants randomized to not receive any drug pre-operative |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SSKI (Potassium Iodide) | Participants randomized to receive 7 days of pre-operative SSKI SSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery |
| BG001 | NO SSKI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data was not collected and therefore cannot be analyzed. | Posted | From Baseline to Immediately Before Surgery |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SSKI (Potassium Iodide) | Participants randomized to receive 7 days of pre-operative SSKI SSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Kuo, MD | Columbia University | 212-305-6969 | jhk2029@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2015 | Aug 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| ID | Term |
|---|---|
| D011193 | Potassium Iodide |
| ID | Term |
|---|---|
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
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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.
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Participants randomized to not receive any drug pre-operative
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants randomized to not receive any drug pre-operative |
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | No SSKI | Participants randomized to not receive any drug pre-operative | 0 | 11 | 0 | 11 | 0 | 11 |
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| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |