Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Not Applicable

Completed

• Conditions: Papillary Thyroid Cancer
• Interventions: Procedure: Total thyroidectomy; Procedure: Total thyroidectomy + prophylactic central neck dissection

• Registration Number: NCT01510002
• Lead Sponsor: Jagiellonian University

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 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 Timeline

• Study Start: 1993-01
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-10
• Last Update Submitted: 2012-01-10
• Study First Posted: 2012-01-13
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TT	Total thyroidectomy	Extracapsular total thyroidectomy
TT+CND	Total thyroidectomy + prophylactic central neck dissection	Extracapsular total thyroidectomy puls prophylactic central neck dissection

Primary Outcome Measures

Name	Time	Method
overall survival	up to 10 years
disease-specific survival	up to 10 years
locoregional control	up to 10 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jagiellonian Univerity, Medical College, 3rd Department of General Surgery; 🇵🇱 Krakow, Malopolska, Poland