The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 cm Papillary Thyroid Carcinoma

N/ANot Yet RecruitingNCT06899347

Leonardo Rossi392 enrolled

Overview

Papillary thyroid carcinoma (PTC) is the most common endocrine malignancy and is frequently associated with microscopic central neck lymph node metastases, even in the absence of preoperative clinical evidence of nodal involvement (cN0). While prophylactic central compartment neck dissection (pCCND) may improve staging accuracy and potentially reduce disease persistence or recurrence, its routine use remains controversial due to the risk of increased surgical morbidity and potential negligible impact on oncologic outcomes. This prospective randomized study aims to evaluate the oncological and surgical outcomes of cN0 PTC patients with tumors measuring 2 to 4 cm who undergo thyroid surgery with or without pCCND. Patients will be treated according to standard clinical practice with either total thyroidectomy (TT) or thyroid lobectomy (TL), and randomized to receive pCCND (bilateral or ipsilateral, respectively) or not. Patients undergoing TT and those undergoing TL will be analyzed separately in two parallel cohorts. The primary objective is to assess the impact of pCCND on disease persistence or recurrence during long-term follow-up. Secondary objectives include evaluation of surgical complications and the impact of pCCND on pathological staging.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

392

Conditions

Papillary Thyroid Carcinoma Central Compartment Neck Dissction

Interventions

Total Thyroidectomy + Central Compartment Neck DissectionPROCEDURE

Thyroidectomy will be performed with the patient in the supine position with the neck hyperextended. A 3 to 6 cm transverse cervicotomy, two fingers above the sternal notch, will be performed, and the midline will be opened. After the inferior laryngeal nerve and parathyroids are visualized, the thyroidectomy will be achieved. When performed, pCCND will aim at removing the nodes of Level VI, which has been reported to contain the thyroid gland and the adjacent nodes bordered superiorly by the hyoid bone, inferiorly by the brachiocephalic artery, and laterally on each side by the carotid sheaths

Thyroid Lobectomy + ipCCNDPROCEDURE

Thyroid lobectomy will be performed with the patient in the supine position with the neck hyperextended. A 3 to 6 cm transverse cervicotomy, two fingers above the sternal notch, will be performed, and the midline will be opened. After identification and preservation of the inferior laryngeal nerve and parathyroid glands, thyroid lobectomy will be completed on the affected side. When performed, ipsilateral prophylactic central compartment neck dissection will aim at removing the lymph nodes of Level VI on the operated side, which includes the prelaryngeal, pretracheal, and ipsilateral paratracheal lymph nodes. The central compartment is bordered superiorly by the hyoid bone, inferiorly by the brachiocephalic artery, and laterally by the carotid sheath on the ipsilateral side.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. PTC documented by fine needle aspiration cytology (FNAC) (TIR 4 or TIR 5 according to the Italian consensus for the classification and reporting of thyroid cytology \[16\]); 2. patients scheduled for thyroid lobectomy or total thyroidectomy; 3. no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US); 4. no clinical evidence of distant metastasis at diagnosis; 5. age ≥ 18 years; 6. signing informed consent. Exclusion criteria: 1. histotypes other than PTC; 2. evidence of lymph node metastases during surgery even if not previously diagnosed; 3. presence of distant metastasis; 4. refusal to sign informed consent. Exit criteria: 1. withdrawal of informed consent; 2. post-operative radioactive iodine therapy.

Outcomes

Primary Outcomes

Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma

Persistent or recurrent disease refers to the presence or reappearance of cancerous tissue despite initial treatment. It is assessed through a combination of biochemical and imaging studies. Biochemically, elevated serum thyroglobulin (Tg) or detectable anti-thyroglobulin antibodies (TgAb) after total thyroidectomy may suggest residual or recurrent disease. Moreover, they may represent a biochemical incomplete or indeterminate response to therapy. On the other hand, imaging techniques such as neck ultrasound or CT scan can identify structural disease.

Time frame: from enrollment to 1, 3, 5 and 10 years

Overall Survival

Overall survival is the most comprehensive indicator of treatment efficacy and patient prognosis. It is typically assessed through survival analysis methods, such as Kaplan-Meier curves, and is expressed as a percentage of patients alive at specific time points.

Time frame: from the enrollment to 1, 3, 5, and 10 years

Secondary Outcomes

Surgical Complications

Complications following thyroidectomy are mainly hypoparathyroidism, vocal cord palsy and bleeding. They are assessed through clinical evaluation, laboratory tests (e.g., calcium and PTH levels for hypoparathyroidism), and laryngoscopy and / or transcutaneous laryngeal ultrasound for vocal cord function.

Time frame: from enrollment to 1, 3, 5 and 10 years

Staging disease

Disease staging will be performed according to the AJCC/TNM system (8th edition) for papillary thyroid carcinoma, assessing tumor size (T), regional lymph node involvement (N), and presence of distant metastases (M); moreover, it will be assessed even according to the latest ATA guidelines (low; low-intermediate; intermediate-high; high).

Time frame: from enrollment to 1, 3, 5 and 10 years