NCT03570021

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid carcinoma comparing: total thyroidectomy alone (experimental group) versus total thyroidectomy + Prophylactic Neck Dissection PND (reference group). Pre-registered patients will be randomized before surgery for tumors with class-6 cytology (Bethesda) or in the operating room after confirmation of malignancy by frozen section analysis for tumors with class-5 cytology.

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
PROCEDURE	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 \[French Society of Otolaryngology Head and Neck Sugery\]. \- The number of lymph nodes resected, the number of metastatic nodes, their size and the presence or absence of extranodal spread will be recorded. Due to the large natural variability of the number of lymph nodes retrieved in a prophylactic neck dissection \[Hartl DM, Ann Surg 2012\], no patient will be excluded on the basis of number of lymph nodes. Furthermore, the participating surgeons routinely perform complete central neck dissections, and were chosen to participate in this study due to a homogenous technique among these surgeons \[Hartl DM, World J Surg 2012\].
PROCEDURE	total thyroidectomy alone without neck dissection	This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery

Timeline

• Start date: 2018-08-08
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2018-06-26
• Last updated: 2026-03-06

Locations

21 sites across 3 countries: France, Guadeloupe, Reunion