Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 392
- 主要终点
- Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma
研究概览
简要总结
Papillary thyroid carcinoma (PTC) is the most common endocrine malignancy and is frequently associated with microscopic central neck lymph node metastases, even in the absence of preoperative clinical evidence of nodal involvement (cN0). While prophylactic central compartment neck dissection (pCCND) may improve staging accuracy and potentially reduce disease persistence or recurrence, its routine use remains controversial due to the risk of increased surgical morbidity and potential negligible impact on oncologic outcomes.
This prospective randomized study aims to evaluate the oncological and surgical outcomes of cN0 PTC patients with tumors measuring 2 to 4 cm who undergo thyroid surgery with or without pCCND. Patients will be treated according to standard clinical practice with either total thyroidectomy (TT) or thyroid lobectomy (TL), and randomized to receive pCCND (bilateral or ipsilateral, respectively) or not. Patients undergoing TT and those undergoing TL will be analyzed separately in two parallel cohorts.
The primary objective is to assess the impact of pCCND on disease persistence or recurrence during long-term follow-up. Secondary objectives include evaluation of surgical complications and the impact of pCCND on pathological staging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •PTC documented by fine needle aspiration cytology (FNAC) (TIR 4 or TIR 5 according to the Italian consensus for the classification and reporting of thyroid cytology [16]);
- •patients scheduled for thyroid lobectomy or total thyroidectomy;
- •no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
- •no clinical evidence of distant metastasis at diagnosis;
- •age ≥ 18 years;
- •signing informed consent.
排除标准
- •histotypes other than PTC;
- •evidence of lymph node metastases during surgery even if not previously diagnosed;
- •presence of distant metastasis;
- •refusal to sign informed consent.
- •Exit criteria:
- •withdrawal of informed consent;
- •post-operative radioactive iodine therapy.
结局指标
主要结局
Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma
时间窗: from enrollment to 1, 3, 5 and 10 years
Persistent or recurrent disease refers to the presence or reappearance of cancerous tissue despite initial treatment. It is assessed through a combination of biochemical and imaging studies. Biochemically, elevated serum thyroglobulin (Tg) or detectable anti-thyroglobulin antibodies (TgAb) after total thyroidectomy may suggest residual or recurrent disease. Moreover, they may represent a biochemical incomplete or indeterminate response to therapy. On the other hand, imaging techniques such as neck ultrasound or CT scan can identify structural disease.
Overall Survival
时间窗: from the enrollment to 1, 3, 5, and 10 years
Overall survival is the most comprehensive indicator of treatment efficacy and patient prognosis. It is typically assessed through survival analysis methods, such as Kaplan-Meier curves, and is expressed as a percentage of patients alive at specific time points.
次要结局
- Surgical Complications(from enrollment to 1, 3, 5 and 10 years)
研究者
Leonardo Rossi
Senior Researcher in General Surgery
University of Pisa