Clinical Trial: Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Brief Summary: The purpose of this study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.

Detailed Summary: Several respected organizations have recently recommended that total thyroidectomy plus prophylactic central neck dissection should be the standard operation for papillary thyroid cancer. However, it is still unclear if this approach has any benefit on survival or locoregional control of the disease. In addition, potential advantages of this more aggressive surgical approach should outweigh the risk of morbidity. The purpose of this retrospective cohort study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative. In this study outcomes of total thyroidectomy versus this plus prophylactic central neck dissection for papillary thyroid cancer are compared in a 10-year follow-up. Patients operated between 1993 and 1997 (n=282) underwent total thyroidectomy alone, whereas patients operated between 1998 and 2002 (n=358) underwent total thyroidectomy plus prophylactic central neck dissection.
Sponsor: Jagiellonian University

Current Primary Outcome:

  • overall survival [ Time Frame: up to 10 years ]
  • disease-specific survival [ Time Frame: up to 10 years ]
  • locoregional control [ Time Frame: up to 10 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of patients with negative serum thyroglobulin levels [ Time Frame: up to 10 years ]
  • postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury). [ Time Frame: up to 12 months ]


Original Secondary Outcome: Same as current

Information By: Jagiellonian University

Dates:
Date Received: January 9, 2012
Date Started: January 1993
Date Completion:
Last Updated: January 10, 2012
Last Verified: January 2012