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

Not Applicable

• Conditions: Thyroid Carcinoma, Papillary; Thyroid Neoplasms; Sentinel Lymph Node; Thyroid Metastases; Thyroid Cancer; Lymph Node Metastases
• Interventions: Procedure: Total thyroidectomy (TT); Procedure: Central lymph node dissection (CLND); Diagnostic Test: Sentinel lymph node (SLN) bopsy; Diagnostic Test: Identification of parathyroid glands (PGs)

• Registration Number: NCT04424485
• Lead Sponsor: Umraniye Education and Research Hospital

Brief 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.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-05
• Last Update Submitted: 2020-06-05
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy	Total thyroidectomy (TT)	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	Central lymph node dissection (CLND)	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
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node	Total thyroidectomy (TT)	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
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node	Sentinel lymph node (SLN) bopsy	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
Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy	Central lymph node dissection (CLND)	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	Identification of parathyroid glands (PGs)	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

Primary Outcome Measures

Name	Time	Method
Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion	1 year	Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast	1 year	İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)

Secondary Outcome Measures

Name	Time	Method
Central lymph node dissetion (CLND)	1 year	Number of positive lymph nodes (micrometastases)

Trial Locations

Locations (1)

Umraniye Education and Research Hospital, Department of General Surgery; 🇹🇷 Istanbul, Turkey