Clinical trial NCT05117853: Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy
Official title: The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thyroid Disease
Hypoparathyroidism Postprocedural
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, comparative, randomized, single-blind, controlled trial against the gold standard of visual identification and viability evaluation.
Primary purpose: PREVENTION

Brief summary: * Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy.
* The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia.
* Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery.
* Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands.
* This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing a total thyroidectomy without previous neck surgery.

Exclusion Criteria:

* Children and teenagers (\<18 years old)
* Patients refusing participation or unable/unwilling to sign the informed consent
* Patients with a completion thyroidectomy
* Patients with planned central and lateral neck lymph node dissections (thyroid cancer)
* Patients with previous neck surgery
* Patients with a known allergy/hypersensitivity to indocyanine green

Primary outcomes:
measure: Postoperative hypocalcemia
timeFrame: One week after surgery
Secondary outcomes:
measure: The number of identified parathyroid glands
timeFrame: 1 hour after surgery
measure: The number of reimplanted parathyroid glands
timeFrame: 1 hour after surgery
measure: The presence of late or permanent hypocalcemia
timeFrame: Six months after surgery
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Hospital
Study officials:
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