The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 cm Papillary Thyroid Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Thyroidectomy + Central Compartment Neck Dissection, Thyroid Lobectomy + ipCCND.
- Who it may be relevant to
- Registry conditions: Papillary Thyroid Carcinoma, Central Compartment Neck Dissction, Thyroidectomy, Thyroid Lobectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma
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.
Interventions
- Procedure Total Thyroidectomy + Central Compartment Neck Dissection
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 h - Procedure Thyroid Lobectomy + ipCCND
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 L
Primary outcome measures
- Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma [Time frame: from enrollment to 1, 3, 5 and 10 years]
- Overall Survival [Time frame: from the enrollment to 1, 3, 5, and 10 years]
Secondary outcome measures (2)
- Surgical Complications [Time frame: from enrollment to 1, 3, 5 and 10 years]
- Staging disease [Time frame: from enrollment to 1, 3, 5 and 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06899347 · 27092