Using fluorescence imaging to protect parathyroid glands during thyroid surgery
Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy
This study is testing if using special imaging during thyroid surgery can help doctors find and protect the parathyroid glands better, which may reduce the risk of complications for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Shandong Linglong Yingcheng Hospital Research network |
| Locations | 1 site (Yantai, Shandong) |
| Trial ID | NCT06288750 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of near-infrared fluorescence imaging, specifically using indocyanine green and autofluorescence, to enhance the identification and preservation of parathyroid glands during total thyroidectomy. By improving the visualization of these glands, the study aims to reduce the incidence of postoperative hypoparathyroidism, a common complication following thyroid surgery. The approach seeks to address the limitations of traditional visual identification methods that rely heavily on the surgeon's experience. The study will involve patients scheduled for elective thyroid surgery and will compare outcomes between those receiving fluorescence imaging and those who do not.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for elective total or hemi thyroidectomy and have normal liver and renal function.
Not a fit: Patients under 18, those with liver or renal insufficiency, or individuals with known hypersensitivity to indocyanine green or iodine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative hypoparathyroidism, improving patient outcomes and quality of life.
How similar studies have performed: While the use of near-infrared fluorescence imaging is gaining traction, this specific combination of techniques for parathyroid protection during thyroid surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Yantai, Shandong
- Shandong Linglong Yingcheng Hospital — Yantai, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Xuan Qiu, MD — Shandong Linglong Yingcheng Hospital
- Study coordinator: Xuan Qiu, MD
- Email: qiuxuan100@163.com
- Phone: 8618354280081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.