Prophylactic Central Neck Dissection for Papillary Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a pathological diagnosis of papillary thyroid cancer,
- •in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation
排除标准
- •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)
结局指标
主要结局
overall survival
时间窗: up to 10 years
disease-specific survival
时间窗: up to 10 years
locoregional control
时间窗: up to 10 years
次要结局
- 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)
研究者
Marcin Barczynski
Principal Investigator
Jagiellonian University