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

NCT03570021 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2026-03-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • France
  • Guadeloupe
  • Reunion

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570021 on ClinicalTrials.gov