Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 14
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
Intrahepatic cholangiocarcinoma (ICC) is one of the common malignant tumors. Lymph node metastasis is an important factor affecting the poor prognosis of intrahepatic cholangiocarcinoma. The eighth edition of the AJCC guidelines recommends at least 6 lymph nodes to be used for staging. The American Hepatobiliary and Pancreatic Association also recommends the removal of hilar lymph nodes as part of the radical surgery for intrahepatic cholangiocarcinoma. However, some scholars have found that patients with regional lymph nodes have similar survival rates. This contradictory result has prompted more scholars to conduct clinical research to explore the necessity and standardization of lymph node dissection in intrahepatic cholangiocarcinoma.
详细描述
Expanding lymph node dissection can theoretically obtain more lymph node dissection. Obtaining enough lymph nodes can improve the accuracy of AJCC staging and accurately determine prognosis. However, it is unclear whether it will improve the prognosis of patients with lymph node dissection. According to literature reports and related studies, expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and left lymphoma expanded lymph node dissection includedstations 12, 1, 3, 7, and 8.
In summary, standardize the extent of lymph node dissection in intrahepatic cholangiocarcinoma, and obtain enough lymph node dissection under the premise of controlling the complication rate, which is helpful for accurate TNM staging, accurate judgment of prognosis and improvement of survival time. Improve prognosis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years of age and ≤80 years of age;
- •Preoperative imaging and laboratory examination for intrahepatic cholangiocarcinoma, intraoperative frozen and postoperative pathology confirmed as intrahepatic cholangiocarcinoma; preoperative imaging assessment is resectable;
- •No obvious lymph node metastasis in preoperative imaging; or negative intraoperative lymph node biopsy
- •Liver function Child-Turcotte-Pugh score A-B grade;
- •Residual liver volume >30%; can tolerate radical hepatectomy
- •The patient has autonomy, understands and voluntarily signs the written informed consent and is able to complete the follow-up plan;
- •Sign the written informed consent form prior to the test screening.
排除标准
- •The patient has obvious heart, lung, brain and kidney dysfunction that affects the treatment of intrahepatic cholangiocarcinoma;
- •The patient has a history of other malignant tumors;
- •Liver function Child-Turcotte-Pugh score C;
- •The investigator determined that it was not suitable for the study.
结局指标
主要结局
Disease free survival (DFS)
时间窗: 5 years after surgery
disease free survival
次要结局
- 3-year Overall survival (OS)(3 years after surgery)
- Rate of Postoperative Complications (PC)(From the date of surgery to stitches off (up to 2 month))
- 5-year Overall survival (OS)(5 years after surgery)