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Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.
Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs) is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. However, TT procedure has some important complications such as vocal cord paralysis (VCP) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG- vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP. However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of TT. Intraoperative identification of SLNs and PGs can help surgeon to overcome these problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy | Active Comparator | Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC) Standard TT+CLND procedure only |
|
| Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node | Experimental | Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND). TT+CLND with NIR fluorescence ICG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total thyroidectomy (TT) | Procedure | Standard TT procedure for thyroid carcinoma, for both groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion | Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy | 1 year |
| Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast | Ä°ntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Central lymph node dissetion (CLND) | Number of positive lymph nodes (micrometastases) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof. | Contact | +90 216 632 1818 | 1950 | drethemunal@gmail.com |
| Sema Yuksekdag, MD | Contact | +90 216 632 1818 | 1950 | drsemayuksekdag@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umraniye Education and Research Hospital, Department of General Surgery | Recruiting | Istanbul | 34760 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31490376 | Result | Zhang X, Shen YP, Li JG, Chen G. Clinical feasibility of imaging with indocyanine green combined with carbon nanoparticles for sentinel lymph node identification in papillary thyroid microcarcinoma. Medicine (Baltimore). 2019 Sep;98(36):e16935. doi: 10.1097/MD.0000000000016935. | |
| 31882459 | Result | Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741. |
| Label | URL |
|---|---|
| Ethem Unal | View source |
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Excel data is available upon request at drethemunal@gmail.com
1 year
Please request study protocol and data (when available) at drethemunal@gmail.com
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| Central lymph node dissection (CLND) | Procedure | Standard CLND for thyroid carcinoma, for both groups |
|
| Sentinel lymph node (SLN) bopsy | Diagnostic Test | Intrathyroidal injection of ICG for SL biopsy, for only experimental group |
|
| Identification of parathyroid glands (PGs) | Diagnostic Test | Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group |
|
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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