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Study on Using Indocyanine Green to Protect Parathyroid Glands During Thyroid Surgery for Patients with Hypothyroidism

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a special dye called Indocyanine Green during thyroid surgery. The trial is particularly interested in patients undergoing a procedure known as a total thyroidectomy, which is the removal of the thyroid gland. This surgery may also involve the removal of lymph nodes in the neck area. The main goal of the study is to see if using Indocyanine Green can help surgeons better identify and preserve the parathyroid glands, which are small glands located near the thyroid that help control calcium levels in the body. By doing so, the study aims to reduce the risk of a condition called hypoparathyroidism, which occurs when the parathyroid glands do not produce enough hormone, leading to low calcium levels.

During the trial, some patients will receive the Indocyanine Green dye, which is injected into the bloodstream. This dye helps highlight the blood vessels and the parathyroid glands during surgery, making it easier for surgeons to see and avoid damaging them. Other patients will undergo the surgery without the use of the dye. The study will compare the outcomes of these two groups to determine if the dye is effective in preserving the parathyroid glands. The trial will also monitor various health indicators, such as calcium and hormone levels, before and after the surgery, and follow up with patients for a year to check for any signs of hypoparathyroidism.

The study is designed to provide valuable information on whether using Indocyanine Green during thyroid surgery can improve patient outcomes by reducing the risk of complications related to the parathyroid glands. This research could potentially lead to better surgical techniques and improved quality of life for patients undergoing thyroid surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is determined for individuals aged 18 or older who require a total thyroidectomy, with or without central cervical lymph node dissection, due to thyroid disease.

    Understanding of the study and agreement to participate is confirmed through signing a written informed consent.

  2. Step 2

    Preoperative assessment

    Before surgery, blood tests are conducted to measure levels of calcium, total protein, vitamin D, and parathyroid hormone (PTH).

  3. Step 3

    Surgery preparation

    The surgical procedure involves the use of indocyanine green (ICG) for intraoperative arteriography. This is administered through an intravenous route to help identify the vascular pattern of the parathyroid glands.

  4. Step 4

    Surgical procedure

    During the surgery, the preservation of the parathyroid glands is assessed with and without the use of ICG arteriography.

    The duration of the surgery is recorded.

  5. Step 5

    Postoperative assessment

    Within 24 hours after surgery, blood tests are repeated to measure serum levels of PTH, calcium, and total protein.

    The number of well-perfused parathyroid glands is evaluated.

  6. Step 6

    Follow-up

    Serum PTH levels are monitored at 1, 3, 6, and 12 months after surgery.

    The presence or absence of hypoparathyroidism is assessed during the one-year follow-up. Hypoparathyroidism is defined as undetectable or inappropriately low serum PTH levels in the context of low calcium levels.

Who can join the trial?

7 criteria

  • Patients must be **18 years of age or older**.
  • Patients need to have a **surgical indication for total thyroidectomy**. This means they need surgery to remove the thyroid gland completely.
  • The surgery can be with or without **central cervical lymph node dissection**. This is a procedure where some lymph nodes in the neck area might be removed.
  • The reason for the surgery should be due to a **thyroid disease**.
  • The patient or their legal guardian must be able to **understand the study** and agree to participate.
  • They must **sign a written informed consent**. This is a document that explains the study and confirms their willingness to join.
  • Both **male and female** patients can participate.

Who cannot join the trial?

1 criterion

  • Patients with **hypothyroidism** cannot participate. Hypothyroidism is a condition where the thyroid gland does not produce enough hormones.
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Investigated drugs

Indocyanine Green (ICG) is a dye used in medical imaging. In this trial, it is used during surgery to help doctors see the blood vessels around the parathyroid glands. This helps the surgeons to avoid damaging these glands during thyroid surgery, which can prevent complications like permanent hypoparathyroidism.

What is already known about the treatment

Indocyanine Green – Indocyanine Green is administered intravenously and is used in medical imaging. It is currently being studied in clinical trials to assess its effectiveness in preserving parathyroid glands during thyroid surgery. The main therapeutic indication for this trial is to prevent permanent hypoparathyroidism by identifying the vascular pattern of the parathyroid glands. At the molecular level, Indocyanine Green works by binding to plasma proteins, allowing it to be visualized using near-infrared fluorescence imaging. It is classified as a diagnostic agent in pharmacology.

Investigated diseases

Hypothyroidism – Hypothyroidism is a condition where the thyroid gland does not produce enough thyroid hormones. These hormones are crucial for regulating the body's metabolism, energy production, and overall growth. As the disease progresses, individuals may experience symptoms such as fatigue, weight gain, cold intolerance, and depression. The condition can also lead to dry skin, hair loss, and muscle weakness. Over time, if left untreated, it can cause more severe symptoms and affect various bodily functions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509130-18-00Protocol codeGUIARTE-HUB-2022Estimated enrolment394 patientsSponsorBellvitge University Hospital

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