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Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy

Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06288750
Enrollment
200
Registered
2024-03-01
Start date
2024-02-01
Completion date
2025-06-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indocyanine Green, Parathyroid Function Low Adverse Event, Parathyroid Glands--Diseases, Total Thyroidectomy

Brief summary

Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy.

Detailed description

Postoperative hypoparathyroidism or hypocalcemia is the most frequent complication after total thyroidectomy (TT) . The median incidence of transient and permanent postoperative hypoparathyroidism is 27% (19%-38%) and 1% (0-3%), respectively. Transient hypoparathyroidism can increase the length of hospital stay and the costs of hospitalization for patients. Permanent hypoparathyroidism leads to lifelong medication use, which may severely impair the quality of life of patients. Therefore, identifying the parathyroid glands (PGs) and preserving those with adequate blood perfusion intraoperatively has always been a crucial procedure during thyroidectomy. Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance (color, shape, etc.) by the naked eye. However, this visual inspection is often influenced by the experience of the surgeon, intraoperative hemorrhage, ectopic PGs and so on, which makes it difficult to fully protect the PGs. Currently, there has been an emergence of near-infrared fluorescence imaging (NIFI) that can be applied during thyroid or parathyroid surgery for the evaluation and identification of PGs. This technique mainly exploits the autofluorescence (AF) of PGs and indocyanine green fluorescence (ICGF ) imaging.PGs could exhibit stronger AF than the surrounding tissue under near-infrared light, which can be exploited to accurately identify PGs in real time. Subsequent studies have demonstrated that AF can not only detect PGs intraoperatively in real time and improve the intraoperative identification of PGs but also reduce the incidence of postoperative hypoparathyroidism. However, AF cannot assess the status of PG blood perfusion and consequently is not useful when determining whether PGs need to be autotransplanted. Indocyanine green (ICG) fluorescence imaging may be a great solution to this problem. ICG is a safe fluorescent dye with fast metabolism and few adverse effects that can quickly combine with plasma proteins after intravenous injection and is widely used in angiography in multiple surgical disciplines. In recent years, several studies have shown that ICGF may be superior in evaluating blood perfusion and predicting the function of PGs in situ, subsequently guiding their autotransplantation. However, ICGF may not be very suitable for the identification of PGs before dissection, as the thyroid gland would also emit intense fluorescence after the injection of ICG, which may lead to difficulties in distinguishing them. Thus, AF and ICGF have their own advantages and disadvantages in the identification and evaluation of PGs, respectively. These two methods can be considered complementary. In the present study, the investigators used AF in combination with ICGF imaging by one fluorescence imaging system during different steps of the surgical procedure. At the beginning of the operation, AF was used to identify the PGs before any dissection. Then, after the thyroid gland was removed, AF was used again to locate the PGs in situ. Finally, ICGF was applied to evaluate the blood perfusion of the PGs in situ and guide their autotransplantation. The aim of this randomized controlled trial was to assess whether this strategy could reduce the incidence of postoperative hypoparathyroidism and benefit the identification and evaluation of PGs during total thyroidectomy.

Interventions

DEVICEIndocyanine Green

ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.

Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance (color, shape, etc.) by the naked eye.

Sponsors

Shandong Linglong Yingcheng Hospital
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Male or female patients, aged 18 years and above * Scheduled for elective total or hemi thyroidectomy * Normal liver and renal function * No known hypersensitivity for iodine or ICG * Able to understand the nature of the study procedures * Willing to participate and give written informed consent

Exclusion criteria

* Age \< 18 years * Liver or renal insufficiency * Known ICG, iodine, penicillin or sulfa hypersensitivity * Pregnancy or breastfeeding * Not able to understand the nature of the study procedure * Not willing to participate

Design outcomes

Primary

MeasureTime frameDescription
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast1 yearİntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)

Secondary

MeasureTime frameDescription
Central lymph node dissetion (CLND)1 yearNumber of positive lymph nodes (micrometastases)

Countries

China

Contacts

Primary ContactXuan Qiu, MD
qiuxuan100@163.com8618354280081
Backup ContactNi Wang, MD,PD
wangni1989@163.com8618705353551

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026