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

Umraniye Education and Research Hospital

Status: Unknown

Conditions: Thyroid Carcinoma, Papillary; Thyroid Metastases; Sentinel Lymph Node; Lymph Node Metastases; Thyroid Neoplasms; Thyroid Cancer

Treatments: Diagnostic Test: Identification of parathyroid glands (PGs); Procedure: Central lymph node dissection (CLND); Diagnostic Test: Sentinel lymph node (SLN) bopsy; Procedure: Total thyroidectomy (TT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04424485

B.10.1.TKH.4.34.H.GP.0.01/213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 17 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure
• Patients at or over 17 years

Exclusion criteria

• Previous thyroid surgery
• Patients below 17 years

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy

Active Comparator group

Description:

Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC) Standard TT+CLND procedure only

Treatment:

Procedure: Central lymph node dissection (CLND)

Procedure: Total thyroidectomy (TT)

Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node

Experimental group

Description:

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

Treatment:

Diagnostic Test: Sentinel lymph node (SLN) bopsy

Diagnostic Test: Identification of parathyroid glands (PGs)

Procedure: Central lymph node dissection (CLND)

Procedure: Total thyroidectomy (TT)