Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcin Barczynski, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01510002
First received: January 9, 2012
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Papillary Thyroid Cancer
Procedure: Total thyroidectomy
Procedure: Total thyroidectomy + prophylactic central neck dissection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • overall survival [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • disease-specific survival [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • locoregional control [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of patients with negative serum thyroglobulin levels [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury). [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 640
Study Start Date: January 1993
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TT
Extracapsular total thyroidectomy
Procedure: Total thyroidectomy
Extracapsular total thyroidectomy
Experimental: TT+CND
Extracapsular total thyroidectomy puls prophylactic central neck dissection
Procedure: Total thyroidectomy + prophylactic central neck dissection
Extracapsular total thyroidectomy plus prophylactic central neck dissection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a pathological diagnosis of papillary thyroid cancer,
  • in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation

Exclusion Criteria:

  • incidental diagnosis of papillary thyroid cancer following hemithyroidectomy and requiring completion thyroidectomy,
  • one-stage lymph nodes dissection based on therapeutic intent,
  • previous thyroid surgery,
  • incomplete follow-up information,
  • incomplete histopathology report,
  • ASA grade higher than 3 (American Society of Anesthesiology)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510002

Locations
Poland
Jagiellonian Univerity, Medical College, 3rd Department of General Surgery
Krakow, Malopolska, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University, Medical College
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcin Barczynski, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier: NCT01510002     History of Changes
Other Study ID Numbers: BBN/501/ZKL/1447
Study First Received: January 9, 2012
Last Updated: January 10, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
papillary thyroid cancer
central neck dissection
survival
locoregional control
morbidity

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 26, 2014