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ACTIVE NOT RECRUITING
NCT03570021
PHASE3

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

View on ClinicalTrials.gov

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

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

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