A Phase 3 interventional study of Autofluorescent detection + Injection of indocyanine green and Gold standard of visual identification and evaluation of viability of the parathyroid glands. in Thyroid Disease and Hypoparathyroidism Postprocedural, sponsored by Onze Lieve Vrouw Hospital. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Onze Lieve Vrouw Hospital · Phase 3, Interventional, and Prevention
Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. When defined as corrected serum calcium levels below 2.10 mmol/L, the temporary rates of hypocalcemia after a total thyroidectomy excluding lymph node neck dissection still easily exceed 20% (BAETS fifth national audit report, 2017). When extending the follow-up period to more than six months after surgery, late or permanent hypocalcemia is seen in over 5% of patients after a total thyroidectomy. These British numbers have been confirmed in large European and American databases. A large, Belgian, single-center analysis, including redo-surgery and lymph node neck dissections, confirmed temporary and permanent rates of hypocalcemia of 32% and 3%, respectively.
While temporary hypocalcemia results in a reduced quality of life, additional medical costs to the patients and the society, and hypocalcemia-related symptoms, permanent hypocalcemia adds an increased risk of developing renal failure, basal ganglia calcifications, neuropsychiatric derangements, and infections.
The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. The visual evaluation of parathyroid gland vascularization is even more challenging, prone to subjectivity, and depending on surgical experience and surgical volume. Moreover, even experienced endocrine surgeons appear to be unreliable in using visual scores to assess the viability of parathyroid glands.
Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. However, this signal does not provide any information on viability and vascularization of the parathyroid glands. Injecting indocyanine green (ICG) and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. The combined technique of autofluorescent and ICG-enhanced imaging suffers from lack of standardization, optimal technique, dosage, and timing of the ICG administration, and still must prove its possible benefit in a clinical setting.
Hence, this randomized clinical trial aims to investigate whether using autofluorescence (AF) and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia. By using parathyroid gland detection via autofluorescence imaging and verifying their viability after ICG injection, the authors aim to identify patients at risk of hypocalcemia.
365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.
This study's planned enrollment of 300 is above the median of 88 across 198 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Onze Lieve Vrouw Hospital is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Drug: indocyanine green (ICG) Autofluorescence detection of the parathyroid glands and injection of indocyanine green at two predefined timepoints will be performed to evaluate the vascularization of the parathyroid glands.
Drug: Autofluorescent detection + Injection of indocyanine green
Gold standard of visual identification and evaluation of viability.
Procedure: Gold standard of visual identification and evaluation of viability of the parathyroid glands.
All four parathyroid glands will be actively sought for in every case selected for the use of AF/ICG, with AF verification of parathyroid tissue. The timepoints of AF will be: * 1 = after lateral dissection side 1 (side 1) * 2= after lateral dissection side 2 (side 2) The timepoints of ICG injection will be: * 1 = after the first thyroid lobectomy (side 1) * 2 = after the second thyroid lobectomy (side 2) Scoring of the viability of parathyroid glands (adapted from Vidal Fortuny et al., 2016): * 1 = black = not viable/vascularized * 2 = grey = moderately viably/ moderately vascularized * 3 = white = viable/well-vascularized
Also known as: ICG Injection
Gold standard of visual identification and evaluation of viability of the parathyroid glands.
Postoperative hypocalcemia
Defined as parathyroid hormone (PTH) levels \<15 pg/mL, serum calcium levels \<2.10 mmol/L, or the intake of calcium or activated vitamin D supplements after total thyroidectomy.
Time frame: One week after surgery
The number of identified parathyroid glands
Visual identification and confirmation with autofluorescence
Time frame: 1 hour after surgery
The number of reimplanted parathyroid glands
Visual identification and decision to re-implant after ICG
Time frame: 1 hour after surgery
The presence of late or permanent hypocalcemia
Defined as persistent PTH levels \<15 pg/mL, persistent serum calcium levels \<2.10 mmol/L, or continued intake of calcium or activated vitamin D supplements more than six months after surgery.
Time frame: Six months after surgery
Plan to share: Yes — All collected data that underlie results in a publication.
Supporting information: Study protocol
Time frame: Data will be available from 1 year after till 20 years after final study completion.
Access criteria: Data access request will be reviewed by the ethics committee of the Onze Lieve Vrouw Hospital, Aalst. Any request will require signing and completing a data access agreement.
Started Nov 2021 (actual). Primary completion is estimated for Oct 2024, 35 months after the start.
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