Neoplasms

All Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Hypoparathyroidism

Hypocalcemia

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Parathyroid Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

All Drugs and Chemicals

Parathyroid Hormone

Previous admitted patients who were given conventional thyroidectomy combined with central neck lymph node dissection, without intra-operative nodes identification were enrolled into control group.

Newly admitted patients,from august 2016 to august 2018, who were given thyroidectomy combined with central neck lymph node dissection, with intra-operative identification of suspicious lymph nodes or parathyroid glands were regarded as experimental group.Intraoperative identification method includes Diff-quik staining and PTH test assay. 200 participants were planed for enrollment.

After needle pucture of suspicious nodes, Diff-quik staining was used to distinct lymph nodes and parathyroid glands. PTH test assay was used for parathyroid identification. Postoperative HE staining were applied as golden standard.

Intraoperative identification method

Rui Ling, Prof.

Meiling Huang, MD

Rui Ling

Juliang Zhang, Doctor

During surgery, a fine needle puncture was proceeded when suspicious nodes was found by clinician. Repeat the punction for 2-3 times from different orientation and then, Diff-quik staining or PTH immunochromatographic assay were proceeded for lymph node or parathyroid glands identification. Post-operative pathology outcome was considered as golden standard.

In the experiment group, when suspicious parathyroid glands or lymph nodes were observed, a 22 G needle was applied for in situ puncture at a 45 degree angle. The needle was initially thrust into the gland for 0.2 mm, and then we advanced the needle for another 0.2mm while gently withdrawing the plunger of the syringe and maintaining negative pressure. At this point, there has parathyroid tissue been adsorbed in the needle. Repeat this process in two different directions to guarantee the simple volume.

When cell smears finished, the smears were fixed in stationary liquid within 2-4 seconds for 5-20 seconds, and then Diff-Quik (DQ) staining technique was proceeded for rapid identification using Diff-Quik staining kit according to the instruction. After the following Diff-quick staining for 30 seconds, we can make out parathyroid cells and lymph nodes under high power microscope.

In addition,PTH immunochromatographic assay kit can also be used for parathyroid glands detection. Using indicator paper to dip to the punctured tissue, the existance of parathyroid glands could be ensured.

HE (Hematoxylin and Eosin) staining was used for pathological verification of suspicious nodes found during surgery. The suspicious nodes occurred in surgery were isolated and fixed with 4% paraformaldehyde for 12 h, embedded in parafﬁn and cut into 3-µm serial sections. Corresponding sections were stained with hematoxylin (BASO Diagnostics Inc. Zhuhai) for 10 min at room temperature. Then, sections were washed with running water. Subsequently, sections were washed with Scott promote blue liquid for 1 min, 1% hydrochloric acid alcohol differentiation liquid for 20 s, and Scott promote blue liquid for 1 min. Then, sections were stained with eosin (BASO Diagnostics Inc. Zhuhai) for 30 s. Sections were washed with running water and sealed for observation. Finally, sections were observed by Image-Pro Plus 5.0 software (Media Cybernetics, Inc., Bethesda, MD, USA).

Intra-operative Rapid Identification of Lymph Node and Parathyroid

Intra-operative Rapid Identification of Lymph Node and Parathyroid by Fine Needle Puncture for Thyroid Carcinoma

Accuracy,sensitivity and specificity of intraoperative identification method

The EORTC QLQ-C30 questionnaire was used to assess the life quality of participances. We calculate the score from 5 functional aspects according to the questionnnaire.

Record the identification time of this novel method and the whole operation time

Xijing Hospital

Professor

Symptoms and General Pathology

Carcinoma, Papillary

Neoplasm Metastasis

Lymphatic Metastasis

Thyroid Cancer, Papillary

Neoplastic Processes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Adenocarcinoma

Adenocarcinoma, Papillary

Bone Density Conservation Agents

Hormones

Calcium

Calcium, Dietary

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

Standard TT+CLND procedure only

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

Standard TT procedure for thyroid carcinoma, for both groups

Total thyroidectomy (TT)

Standard CLND for thyroid carcinoma, for both groups

Central lymph node dissection (CLND)

Intrathyroidal injection of ICG for SL biopsy, for only experimental group

Sentinel lymph node (SLN) bopsy

Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group

Identification of parathyroid glands (PGs)

Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof.

Sema Yuksekdag, MD

Ethem Unal, MD, PhD, A. Prof. of Surgery & Surgical Oncology

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.

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

Excel data is available upon request at drethemunal@gmail.com

Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy

İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)

Number of positive lymph nodes (micrometastases)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intra-operative Rapid Identification of Lymph Node and Parathyroid	NCT03268785	Thyroid Cancer Parathyroid; Ab... Hypocalcemia Hypoparathyroid...	Intraoperative ...	18 Years - 60 Years	Xijing Hospital
Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy	NCT04424485	Thyroid Cancer Thyroid Carcino... Thyroid Metasta... Thyroid Neoplas... Sentinel Lymph ... Lymph Node Meta...	Total thyroidec... Central lymph n... Sentinel lymph ... Identification ...	17 Years - 80 Years	Umraniye Education and Research Hospital
Intra-operative Rapid Identification of Lymph Node and Parathyroid	NCT03268785	Thyroid Cancer Parathyroid; Ab... Hypocalcemia Hypoparathyroid...	Intraoperative ...	18 Years - 60 Years	Xijing Hospital

Spots Global Cancer Trial Database for parathyroid glands