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Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510002
First Posted: January 13, 2012
Last Update Posted: January 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcin Barczynski, Jagiellonian University
  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
Intervention Model: Crossover Assignment
Masking: None (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 Marcin Barczynski, Jagiellonian University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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
First Submitted: January 9, 2012
First Posted: January 13, 2012
Last Update Posted: January 13, 2012
Last Verified: January 2012

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

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