A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Radical Extent of Lymphadenectomy: D2 Dissection vs. Complete Mesocolic Excision, of LAparoscopic Right Colectomy for Right-sided Colon Cancer.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,072
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation.
详细描述
Our study design is a two-arm, parallel-group, single-blind randomized clinical trial. The enrolled colon cancer patients would be divided into the intervention group (CME group) and control group (D2 radical operation group).
The postoperative adjuvant chemotherapy is determined by the pathological results. For patients of stage Ⅲ and patients of stage Ⅱ with unfavorable histologic features, six months of adjuvant chemotherapy of XELOX or fluorouracil-based regimen are recommended.
The postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for curative surgery 18-75years old
- •ASA grade I-III
- •Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
- •Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
- •Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis.
- •Informed consent
排除标准
- •Simultaneous or simultaneous multiple primary colorectal cancer;
- •Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed;
- •Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
- •History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
- •Patients need emergency operation;
- •Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
- •Informed consent refusal
结局指标
主要结局
Disease-free survival
时间窗: 3 years
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
次要结局
- Postoperative complications(30 days)
- Postoperative mortality(30 days)
- 3 years overall survival(3 years)
- Metastasis rate of central lymph node (3rd station)(7 days)
研究者
XIAO Yi, MD
Professor
Peking Union Medical College Hospital