Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Jagiellonian University

Status: Completed

Conditions: Papillary Thyroid Cancer

Treatments: Procedure: Total thyroidectomy + prophylactic central neck dissection; Procedure: Total thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01510002

BBN/501/ZKL/1447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 640 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

TT

Active Comparator group

Description:

Extracapsular total thyroidectomy

Treatment:

Procedure: Total thyroidectomy

TT+CND

Experimental group

Description:

Extracapsular total thyroidectomy puls prophylactic central neck dissection

Treatment:

Procedure: Total thyroidectomy + prophylactic central neck dissection