Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
试验速览
- 阶段
- 不适用
- 入组人数
- 582
- 主要终点
- Disease-free survival
研究概览
简要总结
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.
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
- Double (Participant, 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
- •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 T stage 1-4 and N stage 0-2; there is no distant metastasis.
- •Informed consent
排除标准
- •Simultaneous or simultaneous multiple primary colorectal cancer;
- •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;
- •Patients need emergency operation;
- •Not suitable for laparoscopic surgery;
- •Women during Pregnancy or breast feeding period;
- •Informed consent refusal
研究组 & 干预措施
Complete Mesocolic Excision
the group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.
干预措施: CME (Procedure)
D3 lymph node dissection
the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group.
干预措施: D3 (Procedure)
结局指标
主要结局
Disease-free survival
时间窗: 3 years
次要结局
- 3 years overall survival(3 years)
- The rate of local and distant recurrence(3 years)
- The accuracy of preoperative staging with CT(14 days)
- The rate of postoperative complications and mortality(30 days)