NCT04424485

Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy

Near-infrared (NIR) Fluorescence Imaging With Indocyanine Green (ICG) for Identification of Sentinel Lymph Nodes and Parathyroid Glands During Total Thyroidectomy: Prospective Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Umraniye Education and Research Hospital · Other Government
• Sex: All
• Age: 17 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thyroid Cancer
• Thyroid Carcinoma, Papillary
• Thyroid Metastases
• Thyroid Neoplasms
• Sentinel Lymph Node
• Lymph Node Metastases

Interventions

Type	Name	Description
PROCEDURE	Total thyroidectomy (TT)	Standard TT procedure for thyroid carcinoma, for both groups
PROCEDURE	Central lymph node dissection (CLND)	Standard CLND for thyroid carcinoma, for both groups
DIAGNOSTIC_TEST	Sentinel lymph node (SLN) bopsy	Intrathyroidal injection of ICG for SL biopsy, for only experimental group
DIAGNOSTIC_TEST	Identification of parathyroid glands (PGs)	Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

1 site across 1 country: Turkey (Türkiye)