Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05130476 |
| Other study ID # |
S-20200154 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
