The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 Cm Papillary Thyroid Carcinoma (PRO-COMAND)

Leonardo Rossi

Status: Not yet enrolling

Conditions: Papillary Thyroid Carcinoma; Thyroidectomy; Central Compartment Neck Dissction

Treatments: Procedure: Total Thyroidectomy + Central Compartment Neck Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06899347

27092_MATERAZZI

Details and patient eligibility

About

This randomized prospective study aims to evaluate the advantages and disadvantages (both oncologic and surgical) of prophylactic central compartment neck dissection for clinically node-negative 2-4 cm papillary thyroid carcinoma patients who have been treated either with total thyroidectomy alone or with total thyroidectomy + prophylactic central compartment neck dissection .

Enrollment: 196 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 [15]);
2. no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
3. no clinical evidence of distant metastasis at diagnosis;
4. age ≥ 18 years.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

Total Thyroidectomy

No Intervention group

Total Thyroidectomy + pCCND

Experimental group

Treatment:

Procedure: Total Thyroidectomy + Central Compartment Neck Dissection