Thyroid
Conditions
Brief summary
The research project is an open, parallel-group, single centre, randomized controlled trial that aims to assess the feasibility of measuring iodolipids in thyroid samples of patients during routine thyroid surgery.
Detailed description
Twenty subjects will be included. Patients are randomized 1:1 to receive either a single oral administration of a pharmacological dose of potassium iodide 20±4 hours before surgery (10 patients), or nothing (10 patients): * The dose administered will be 97.5 mg, * Patients allocated to the control group will not receive any drug. Two thyroid samples will be taken from the surgical specimen by a pathologist. Each sample will have a weight of approximatively 1 g, corresponding to a volume of approximately 1 cm3. We will select material containing tissue that corresponds to normal thyroid parenchyma (according to the preoperative ultrasound and direct inspection by the pathologist intraoperatively). The sample will be taken in the dedicated room next to the operating room by a pathologist who will confirm that the targeted area has no visible macroscopic lesion. In case of doubt, an alternative area free of lesion will be selected by the pathologist. Patients are unblinded. The total maximum duration of the study for an individual patient is 42 days. The total duration of the clinical trial will be 3 years in order to include 20 patients.
Interventions
DRUGPotassium iodide
Patients will receive a single oral administration of a pharmacological dose (97.5 mg) of potassium iodide 20±4 hours before surgery.
Sponsors
Prof. Gerasimos Sykiotis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients fulfilling all of the following inclusion criteria are eligible for the study: 1. Patients with the capacity for discernment and who agree to participate in the study and sign the consent. 2. Age ≥18 years. 3. Indication for thyroid surgery due to either nontoxic single thyroid nodule (WHO disease classification 5A01.1) or nontoxic multinodular goitre (WHO disease classification 5A01.2). 4. Normal thyroid function without anti-thyroid medication. This is ascertained by at least one serum TSH value within the reference range in the three months before surgery (if multiple values are available, the latest value should be normal). If no TSH values are available, a blood draw will be performed to measure TSH.
Exclusion criteria
The presence of any one of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean 2-iodoxehadecanal and delta-iodolactone in the thyroid sample | 20±4 hours after administration of potassium iodide |
Contacts
Primary ContactProf. Gerasimos Sykiotis, MD, PhD
Outcome results
None listed