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ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2018-08-08
Completion Date
2027-12
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
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 \[Hartl DM, World J Surg 2012\].
total thyroidectomy alone without neck dissection
This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery
Locations (21)
Gustave Roussy
Villejuif, Val de Marne, France
CHU d'Angers
Angers, France
Hôpital Saint André
Bordeaux, France
Institut Bergonié
Bordeaux, France
Groupement Hospitalier Est
Bron, France
Centre François Baclesse
Caen, France
Jean Perrin
Clermont-Ferrand, France
Centre Georges François Leclerc
Dijon, France
CH de Haguenau
Haguenau, France
CHU Lille, Hôpital Claude Huriez
Lille, France
CHU Nimes
Nîmes, France
CHU de Poitiers
Poitiers, France
CHU Reims - Hôpital Robert Debré
Reims, France
Institut Godinot
Reims, France
Centre Henri Becquerel
Rouen, France
Institut de Cancérologie Strasbourg
Strasbourg, France
Institut Claudius Régaud
Toulouse, France
CHU de Toulouse Hôpital Larrey
Toulouse, France
CHRU Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
CHU de Pointe à Pitre
Les Abymes, Guadeloupe
Clinique Saint Vincent
Réunion, Reunion