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

NCT ID: NCT06899347

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2035-04-30

Brief Summary

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 .

Conditions

Papillary Thyroid Carcinoma; Central Compartment Neck Dissction; Thyroidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Total Thyroidectomy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Total Thyroidectomy + pCCND

Group Type: EXPERIMENTAL

Total Thyroidectomy + Central Compartment Neck Dissection

Intervention Type: 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

Interventions

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 hyoid bone, inferiorly by the brachiocephalic artery, and laterally on each side by the carotid sheaths

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leonardo Rossi

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Rossi

Senior Researcher in General Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

27092_MATERAZZI

Identifier Type: -

Identifier Source: org_study_id