Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

A further objective is to identify events associated with high risk of local recurrence and distant metastases.

Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Inclusion Criteria:

• Age >or =18
• Suspicious nodule < or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
• Cytology consistent with the TIR4 or TIR 5 class
• Sieric TSH in th standard range (with or without levo-tyroxin therapy)
• Normal string motility to fibrolaringoscopy
• Written informed consent

Exclusion Criteria:

• Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures
• Calcitonin increase above normal levels
• Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
• any Contraindications to surgery