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

NCT06899347 | Not Yet Recruiting

• 1 other identifier: 27092
• Study Type: interventional
• Target: 392
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Papillary Thyroid Carcinoma; Thyroidectomy; Thyroid Lobectomy; Central Compartment Neck Dissction

Keywords

papillary thyroid carcinoma; prophylactic central compartment neck dissection; thyroidectomy; surgical complications; outcomes; thyroid lobectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  from the enrollment to 1, 3, 5, and 10 years

Secondary Outcomes (2)

• Surgical Complications

  from enrollment to 1, 3, 5 and 10 years

• Staging disease

  from enrollment to 1, 3, 5 and 10 years

Study Arms (4)

Total Thyroidectomy

NO INTERVENTION

Total Thyroidectomy + pCCND

EXPERIMENTAL

Procedure: Total Thyroidectomy + Central Compartment Neck Dissection

Thyroid Lobectomy

NO INTERVENTION

Thyroid Lobectomy + ipCCND

EXPERIMENTAL

Procedure: Thyroid Lobectomy + ipCCND

Interventions

Total Thyroidectomy + Central Compartment Neck Dissection PROCEDURE

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

Total Thyroidectomy + pCCND

Thyroid Lobectomy + ipCCND PROCEDURE

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.

Thyroid Lobectomy + ipCCND

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[16\]);
• patients scheduled for thyroid lobectomy or total thyroidectomy;
• no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
• no clinical evidence of distant metastasis at diagnosis;
• age ≥ 18 years;
• signing informed consent.

You may not qualify if:

• histotypes other than PTC;
• evidence of lymph node metastases during surgery even if not previously diagnosed;
• presence of distant metastasis;
• refusal to sign informed consent.
• Exit criteria:
• withdrawal of informed consent;
• post-operative radioactive iodine therapy.

Sponsors & Collaborators

• Leonardo Rossi: lead

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher in General Surgery

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 27, 2025
• Study Start: April 28, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2036
• Last Updated: May 5, 2026

Record last verified: 2026-01