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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06899347
• Lead Sponsor: Leonardo Rossi

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-04-01
• Primary Completion: 2026-04
• Study Completion: 2035-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma	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.
Overall Survival	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 Outcome Measures

Name	Time	Method
Surgical Complications	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.