ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer

Recruitment & Eligibility

Inclusion Criteria

Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2)
- AND with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary thyroid carcinoma" (Type 6 according to the Bethesda classification (Appendix 2)
- OR with FNAB cytology "suspicious for malignancy" (Type 5 according to the Bethesda classification). In this latter case, randomization will be performed if confirmation of papillary carcinoma on intraoperative frozen section analysis
cN0: absence of lymph nodes suspicious for malignancy on preoperative ultrasound performed by the center's designated radiologist according to a standardized report
Absence of a medical contra indication to performing a total thyroidectomy with or without bilateral prophylactic neck dissection of the central compartment
Women of childbearing potential should have a negative pregnancy test (serum or urine) before any radioiodine administration. Sexually active patients must agree to use an effective method of contraception or to abstain from sexual activity during the study and for at least 6 months after last dose of radioiodine.
Patient affiliated to a social security regimen or beneficiary of such regimen
Patients age ≥ 18 years old, french-speaking
Patients should understand, sign and date the written informed consent form prior to any protocol specific procedures. Patients should be able and willing to comply with study visits.

Exclusion Criteria

Tumors > 40 mm (cT3) or ≤ 10 mm
Tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively (cT3T4)
Metastatic neck lymph nodes or suspicious neck nodes on preoperative ultrasound (cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle washout fluid will be performed
Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis
Medullary thyroid carcinoma on FNAB cytology and/or with basal serum calcitonin >50 pg/ml
Preoperative or intra-operative suspicion of non-papillary thyroid carcinoma or aggressive histopathological subtype or poorly differentiated carcinoma
Distant metastases (M1) apparent pre-operatively (found due to symptoms or fortuitously; no specific pre-operative work-up will be performed, however, in accordance with current clinical practice)
Recurrent nerve paralysis visualized on systematic pre-operative laryngoscopy and/or abnormal preoperative serum calcium
Pregnant or breast feeding women
Participation in another therapeutic clinical trial within one year from study entry
Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Study & Design

Arm && Interventions

Group	Intervention	Description
Group 1	total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection	total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection as defined by the American Thyroid Association \[American Thyroid Association Surgery Working Group, Thyroid 2009\]. This is a standard treatment recognized by the French Society of Otolaryngology Head and Neck Surgery \[French Society of Otolaryngology Head and Neck Sugery\].
Group 2	total thyroidectomy alone without neck dissection	total thyroidectomy alone without neck dissection. This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery

Primary Outcome Measures

Name	Time	Method
Rate of patients in complete remission	1 year after randomization

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility