Ongoing Clinical Trials for Patients Undergoing Thyroidectomy
Currently, there are 2 ongoing clinical trials focused on improving outcomes for patients undergoing thyroidectomy, a surgical procedure to remove the thyroid gland. These studies are investigating ways to prevent common complications after surgery, such as low calcium levels and damage to the parathyroid glands. Trials are being conducted in France and Spain, exploring different approaches including vitamin D supplementation before surgery and the use of special imaging dyes during the procedure.
Clinical trial locations
- France
- Spain
Study on Preventing Low Calcium Levels After Thyroid Surgery with Preoperative Cholecalciferol Supplementation for Patients Undergoing Total Thyroidectomy
This trial is being conducted in France and focuses on preventing a common complication called hypocalcemia, which is when calcium levels in the blood drop too low after thyroid surgery. This can cause uncomfortable symptoms like tingling in the fingers or around the mouth, muscle cramps, and in more severe cases, muscle spasms and stiffness.
Main inclusion criteria: To participate in this study, you must be at least 18 years old and scheduled to have your entire thyroid gland removed (total thyroidectomy) for any medical reason. You need to be able to provide written informed consent, meaning you understand the study and agree to take part. You must also be affiliated with the social security system.
Main exclusion criteria: You cannot join this study if you belong to a vulnerable population that might need special protection or care. The study is open to both men and women within the specified age range.
Focus and goal: The main goal of this trial is to see if taking a vitamin D supplement called cholecalciferol before surgery can help reduce the chances of developing low calcium levels afterward. The supplement being used is an oral solution called UVEDOSE 100,000 UI. Before your surgery, you will take this supplement by mouth as directed. After the procedure, your calcium levels will be closely monitored for the first 15 days, and you will be watched for symptoms like tingling, muscle spasms, or numbness. If needed, you may receive additional treatment with calcium gluconate to manage low calcium levels. The study will also track how long you stay in the hospital and measure your vitamin D levels before and after surgery to see how well the supplement works.
Investigational drug: Cholecalciferol is a form of vitamin D that helps your body absorb calcium better. By boosting vitamin D levels before the operation, doctors hope to reduce the risk of developing hypocalcemia and improve recovery after surgery.
Study on Using Indocyanine Green to Protect Parathyroid Glands During Thyroid Surgery for Patients with Hypothyroidism
This trial is taking place in Spain and is investigating whether using a special dye called Indocyanine Green during surgery can help protect the parathyroid glands. These are small glands located near the thyroid that help control calcium levels in your body. Sometimes during thyroid surgery, these glands can be accidentally damaged, leading to a condition called hypoparathyroidism where they don’t produce enough hormone, causing low calcium levels.
Main inclusion criteria: You must be 18 years of age or older and need to have your entire thyroid gland removed (total thyroidectomy) due to thyroid disease. The surgery may or may not include removal of some lymph nodes in the neck area. You or your legal guardian must be able to understand the study and agree to participate by signing a written informed consent. Both men and women can join this study.
Main exclusion criteria: You cannot participate if you have hypothyroidism, which is a condition where the thyroid gland does not produce enough hormones.
Focus and goal: The study aims to determine if using Indocyanine Green dye during surgery can help surgeons better see and preserve the parathyroid glands, reducing the risk of hypoparathyroidism. Some patients will receive the dye, which is injected into the bloodstream and helps highlight blood vessels and the parathyroid glands during surgery, making them easier to see and avoid damaging. Other patients will have surgery without the dye. Before surgery, blood tests will measure your calcium, protein, vitamin D, and parathyroid hormone levels. During surgery, doctors will assess how well the parathyroid glands are preserved with and without the dye. Within 24 hours after surgery, blood tests are repeated, and the number of well-functioning parathyroid glands is evaluated. You will be followed for one year, with hormone levels checked at 1, 3, 6, and 12 months to assess for any signs of hypoparathyroidism.
Investigational drug: Indocyanine Green is a dye used in medical imaging. When administered intravenously during surgery, it helps doctors see the blood vessels around the parathyroid glands using special near-infrared fluorescence imaging. This helps surgeons avoid damaging these important glands, which can prevent complications like permanent hypoparathyroidism.
Summary
These two clinical trials represent important research efforts to improve outcomes for patients undergoing thyroid surgery. Both studies address different but equally important complications that can occur after thyroidectomy. The French trial focuses on preventing low calcium levels by using vitamin D supplementation before surgery, while the Spanish trial explores the use of advanced imaging technology during surgery to protect the parathyroid glands.
It is notable that both trials are taking complementary approaches to similar problems—preventing hypocalcemia and protecting parathyroid function. The French study tests a simple, non-invasive intervention that patients can take before surgery, while the Spanish study evaluates a more sophisticated surgical technique that requires specialized equipment and training. Together, these studies may provide valuable insights into multiple strategies for reducing complications and improving recovery for patients undergoing thyroid surgery.
