Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

January 10, 2012 updated by: Marcin Barczynski, Jagiellonian University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 31-202
        • Jagiellonian Univerity, Medical College, 3rd Department of general Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: up to 10 years
up to 10 years
disease-specific survival
Time Frame: up to 10 years
up to 10 years
locoregional control
Time Frame: up to 10 years
up to 10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1993

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBN/501/ZKL/1447

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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