Clinical trial NCT05130476: Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Thyroidectomy
Official title: Intraoperative Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Total and Completion Thyroidectomy: a Matched Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoparathyroidism Postprocedural
Keywords: Near-infrared fluorescence
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Matched cohort study
Primary purpose: PREVENTION

Brief summary: The parathyroid glands and their blood vessels are notoriously difficult to visualize and may therefore be unintentionally and irrevocably damaged during thyroid surgery. This project investigates new surgeon-performed imaging techniques that visualize the parathyroid glands and their vessels in real-time during thyroid surgery. The purpose is to examine, in a matched cohort study, whether the implementation of near-infrared-induced autofluorescence for identification of the parathyroid glands, combined with indocyanine green near-infrared angiography of the parathyroid feeding vessels, can reduce the incidence of postoperative hypocalcaemia in patients undergoing total and completion thyroidectomy at Odense University Hospital.

Detailed description: The most common complication after thyroidectomy is postoperative hypoparathyroidism due to unintentional intraoperative injury, excision, or devascularisation of the parathyroid glands. This complication can be either transient (≤6 months), or permanent (\> 6 months). The pooled results from four recent studies from three different Danish university hospitals show that 117/945 patients (12.4%) suffered from permanent hypoparathyroidism after total and completion thyroidectomy. This is a very high percentage, considering that the consequences of hypoparathyroidism and its treatment may be severe and include prolonged hospitalization, neuromuscular symptoms, nephrocalcinosis, nephrolithiasis, premature cataracts, seizures, basal ganglia calcification, and increased mortality.

To minimize the risk of postoperative hypoparathyroidism, the standard approach to thyroidectomy is to keep dissection as close to the thyroid capsule as possible while visually scrutinizing the surgical field for the parathyroid glands and their delicate feeding vessels. In spite of these measures, the reported incidences of transient and permanent hypocalcaemia clearly demonstrate a need to further decrease the risk of inadvertent injury to the parathyroid glands and their vessels during thyroid surgery. To achieve this goal, surgeons need a reliable intraoperative aid that can 1) help them identify the parathyroid glands in vivo and 2) locate their feeding vessels and evaluate their perfusion in real-time during thyroid surgery. Recently, two near-infrared fluorescence techniques have emerged, that could potentially meet the requirement of identifying the parathyroid glands and assessing their vasculature using the same piece of technical equipment. The techniques are: near-infrared-induced autofluorescence of the parathyroid glands (NIRAF) for parathyroid identification, and indocyanine green near-infrared angiography (ICGA) for the assessment of parathyroid vascularization. A recent systematic review concluded that these most reported-on optical tools for parathyroid identification and perfusion assessment are favourable for clinical application in terms of being real-time and non-invasive, having a high sensitivity, an excellent safety profile, and involving no exposure to ionizing radiation. Prior to a broader implementation, commercially unaffiliated investigator-initiated studies are needed to evaluate the clinical effect of the bimodal application of NIRAF and ICGA on the incidence of postoperative hypoparathyroidism after total and completion thyroidectomy. This study intends to address this need.

The hypothesis of the study is that near-infrared-induced autofluorescence (NIRAF) combined with indocyanine green near-infrared angiography (ICGA) of the parathyroid glands can reduce the incidence of permanent hypoparathyroidism after total and completion thyroidectomy to 1/3 or less of the incidence in a matched retrospective control group.

Eligibility criteria: Inclusion Criteria:

• Patients 18 years and older who are scheduled to undergo total or completion thyroidectomy at the department of Oro-Rhino-Laryngology (ORL) and Head and Neck Surgery at Odense University Hospital, Denmark.

Exclusion Criteria:

* Not legally competent.
* Does not read or speak Danish.
* Is pregnant or nursing.
* Suffers from chronic kidney disease with an estimated glomerular filtration rate \< 45 ml/min/1.73m2.
* Has a history of allergy to iodides or to indocyanine green.
* Suffers from hyperparathyroidism, hypoparathyroidism, or hypocalcaemia prior to surgery.
* Prescription use of supplemental active vitamin D: dihydrotachysterol (ATC 11CC02), alfacalcidol (ATC A11CC03), or calcitriol (ATC A11CC04).
* Patients scheduled to have a radioactive iodine uptake study performed ≤ 7 days after the thyroidectomy.

Primary outcomes:
measure: Permanent hypoparathyroidism 12 months after surgery
timeFrame: 12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
References: