Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- rate of disease recurrence
研究概览
简要总结
It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases.
For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.
详细描述
Routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver metastases may improve outcome of further patients due to the presence of micrometastases that have been shown to be of prognostic relevance. While previous studies highlight the clinical significance of perihepatic lymph node metastases, the outcome of patients with and without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about the clinical value of routine hilar lymphadenectomy in CRC patients undergoing resection of liver metastases can be drawn from present data.
As disease recurrence occurs frequently and may affect up to 75 % of patients, further strategies are required to improve postoperative outcome. Routine hilar lymphadenectomy may offer an effective approach to remove residual disease and by this to reduce disease recurrence with little additional morbidity. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients scheduled for curative (R0) resection
- •No evidence of extrahepatic disease
- •No history of previous hepatic lymphadenectomy
- •Age equal or greater than 18 years
- •Written Informed consent
排除标准
- •Expected lack of compliance
- •Impaired mental state or language problems
- •History of another primary cancer, except:
- •Curatively treated in situ cervical cancer or curatively resected non-melanoma skin cancer
- •Other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years prior to randomisation
研究组 & 干预措施
Group A: No routine hilar lymphadenectomy
Resection of colorectal liver metastases without routine hilar lymphadenectomy
Group B: Routine hilar lymphadenectomy
Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases.
干预措施: Routine hilar lymphadenectomy (Procedure)
结局指标
主要结局
rate of disease recurrence
时间窗: 2 years after surgery
次要结局
未报告次要终点
研究者
Nuh Rahbari
PD MD
University Hospital Carl Gustav Carus