Indocyanine Green Clinical Trial
Official title:
Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Shandong Linglong Yingcheng Hospital | Yantai | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong Linglong Yingcheng Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast | Intravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not) | 1 year | |
Secondary | Central lymph node dissetion (CLND) | Number of positive lymph nodes (micrometastases) | 1 year |
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