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Completed

NCT Number: NCT01510002

Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

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.

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Key information

Conditions

Papillary Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian Univerity, Medical College, 3rd Department of General Surgery

Krakow, Malopolska, 31-202, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Total thyroidectomy

Procedure

Extracapsular total thyroidectomy

Total thyroidectomy + prophylactic central neck dissection

Procedure

Extracapsular total thyroidectomy plus prophylactic central neck dissection

Primary outcomes

  1. overall survival

    Time frame: up to 10 years

  2. disease-specific survival

    Time frame: up to 10 years

  3. locoregional control

    Time frame: up to 10 years

Secondary outcomes

  1. number of patients with negative serum thyroglobulin levels

    Time frame: up to 10 years

  2. postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Important dates

Study start
1993
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2012
Registry last updated
Jan 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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