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NCT Number: NCT06899347

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

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.

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Key information

Conditions

Papillary Thyroid Carcinoma Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Central Compartment Neck Dissction Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Lobectomy Thyroid Neoplasms Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma

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

    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.

  2. Overall Survival

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

    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.

Secondary outcomes

  1. Surgical Complications

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

    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.

  2. Staging disease

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

    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).

Sponsors and collaborators

Lead sponsor

Leonardo Rossi

Other

Registry information

Official study title

Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma

Acronym: PRO-COMAND

Important dates

Study start
2026
Primary completion
2027
Study completion
2036
First posted
Mar 27, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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