Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Conditions
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Papillary Thyroid Cancer

Intervention / Treatment
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* Procedure: Total thyroidectomy
* Procedure: Total thyroidectomy + prophylactic central neck dissection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TT<br>Extracapsular total thyroidectomy | Procedure: Total thyroidectomy<br>* Extracapsular total thyroidectomy<br>|
| Experimental: TT+CND<br>Extracapsular total thyroidectomy puls prophylactic central neck dissection | Procedure: Total thyroidectomy + prophylactic central neck dissection<br>* Extracapsular total thyroidectomy plus prophylactic central neck dissection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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papillary thyroid cancer, central neck dissection, survival, locoregional control, morbidity