A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer.
详细描述
Laparoscopic complete mesocolic excision (CME) in treating colon cancer has been reported to be feasible and safe and holds many advantages when compared with traditional open surgery, such as reducing preoperative blood loss, alleviating postoperative pain and reducing complications and length of hospital stay. Whether laparoscopic CME could achieve an equivalent oncological outcome, especially for locally advanced malignancy, is still being discussed.
The purpose of this study is to determine the short and long outcomes of open and laparoscopic CME for locally advanced colon cancer patients. The primary endpoint is the 5-year disease-free survival rate. Secondary endpoints include completeness of mesocolon, morbidity and mortality, local recurrence, overall survival, quality of life et al.
In this study, eligible patient will be randomly allocated to receive either open or laparoscopic CME surgery. Randomization will be performed centrally and be stratified for age, gender, T-stage, tumor location. Patients will be randomized in a 2:1 ratio, in favor of the laparoscopic CME.
The extent of resection according to CME principle is identical for both arms. CME involves the removal of the afflicted colon and its accessory lymphvascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Type of anastomosis, location of auxiliary incision and drainage of surgical field are up to the discretion of the surgeon. In laparoscopic surgery, a "medial-to-lateral" approach and a no-touch isolation are required .
Intraoperative pictures were taken at various stages, as were photographs of the postoperative specimen, which will be assessed by a third-party expert to qualify the surgery.
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
- None
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 suitable for curative surgery over 18 years old;
- •American Society of Anesthesiologists(ASA) grade I-III;
- •Pathological diagnosis of adenocarcinoma;
- •Tumor located between the cecum and sigmoid colon;
- •Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
- •Informed consent;
- •No preoperative chemoradiotherapy;
- •No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
排除标准
- •Pregnant patient;
- •History of psychiatric disease;
- •Use of systemic steroids;
- •Conversion to laparotomy;
- •Simultaneous or simultaneous multiple primary colorectal cancer;
- •Preoperative imaging examination results show:
- •Tumor involves the surrounding organs and combined organ resection need to be done;
- •distant metastasis;
- •unable to perform R0 resection;
- •Postoperative pathology of T1-T2 N0;
- •History of any other malignant tumor in recent 5 years;
- •Patients need emergency operation: mechanic ileus, perforation.
- •Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
结局指标
主要结局
disease-free survival
时间窗: 5 years
次要结局
- length of postoperative hospital stay(30 days)
- operative time(1 day)
- recurrence-free survival(5 years)
- local recurrence rate(5 years)
- postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire(5 years)
- overall survival(5 years)
- number of lymph nodes retrieved(1 day)
- early complication rate(30 days)
- completeness of the mesocolon of the specimen(1 day)
研究者
Yueming Sun
Director of the Colorectal Surgery Department
The First Affiliated Hospital with Nanjing Medical University