Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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):
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental |
| |
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium iodide | Drug | Patients will receive a single oral administration of a pharmacological dose (97.5 mg) of potassium iodide 20±4 hours before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 2-iodoxehadecanal and delta-iodolactone in the thyroid sample | 20±4 hours after administration of potassium iodide |
Not provided
Not provided
Inclusion Criteria:
Patients fulfilling all of the following inclusion criteria are eligible for the study:
Exclusion Criteria:
The presence of any one of the following exclusion criteria will lead to exclusion of the patient:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Gerasimos Sykiotis, MD, PhD | Contact | +41 (0)79 556 14 94 | Gerasimos.Sykiotis@chuv.ch |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011193 | Potassium Iodide |
| ID | Term |
|---|---|
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided