D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,381
- 试验地点
- 2
- 主要终点
- 5-year overall survival
研究概览
简要总结
The efficiency of the D3 lymph node dissection is still controversial for left colon cancer patients. This study will try find difference in 5-year overall survival between D2 and D3 lymph node dissection. Investigation of the functional and short-term outcomes will clarify safety of the D3 lymph node dissection.
详细描述
Discussion about optimal type of lymph node dissection in colorectal cancer continues during last 15 years, when in Europe was presented concept of complete mesocolic excision. However, this concepts is very close to Japanese D3 lymph node dissection and in the first view it seems the same but principal differences were found. Japanese concept is partial resection of the bowel according feeding artery (short bowel specimen, long lymphovascular pedicle), opposite European concept is wide resection of the bowel like hemicolectomy or extended hemicolectomy, sigmoidectomy. In complete mesocolic excision anatomical landmarks are still unclear but in Japanese guidelines it has anatomical margins which can standardize this procedure. Also nerve sparing technique around root of inferior mesenteric artery was described. One more difference is in histological examination of the specimen. European concept is to pay more attention to the quality of complete mesocolic excision and less - to the number of investigated lymph nodes. In Japan lymph node extraction is performed by surgical team from the fresh specimen and send to pathologist separately (each group of lymph nodes). Considering the absence of randomized control trials for patients with left colon cancer DILEMMA trial was started using Japanese approach
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreement of the patient to participate in trial
- •Colon cancer (only adenocarcinoma )
- •The tumor located between the splenic flexure and rectosigmoid junction
- •Tolerance of chemotherapy
排除标准
- •сТis - Т2, сТ4b (tail of the pancreas, stomach, small bowel, ureter, urinary bladder)
- •Preoperative complications of the tumor (perforation and full bowel
- •obstruction)
- •Previous radiotherapy or chemotherapy
- •Synchronous or metachronous tumors
- •Women during Pregnancy or breast feeding period
研究组 & 干预措施
D2 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232 and 231 will be removed.
For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and partially 241, 242 (considering variation of the feeding artery) will be removed.
For tumours in the mid part of sigmoid colon lymph nodes 241, 242 will be removed.
For tumours in the rectosigmoid junction 251, 252 groups of the lymph node will be removed.
干预措施: Left colon resection (Procedure)
D2 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232 and 231 will be removed.
For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and partially 241, 242 (considering variation of the feeding artery) will be removed.
For tumours in the mid part of sigmoid colon lymph nodes 241, 242 will be removed.
For tumours in the rectosigmoid junction 251, 252 groups of the lymph node will be removed.
干预措施: Sigmoid colon resection (Procedure)
D2 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232 and 231 will be removed.
For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and partially 241, 242 (considering variation of the feeding artery) will be removed.
For tumours in the mid part of sigmoid colon lymph nodes 241, 242 will be removed.
For tumours in the rectosigmoid junction 251, 252 groups of the lymph node will be removed.
干预措施: Distal sigmoid colon resection or anterior resection (Procedure)
D3 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232, 231 and 253 will be removed.
For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and 253 and partially 241, 242 (considering variation of the feeding artery) will be removed.
For tumours in the mid part of sigmoid colon lymph nodes 241, 242 and 253 will be removed.
For tumours in the rectosigmoid junction 251, 252 and 253 groups of the lymph node will be removed.
干预措施: Distal sigmoid colon resection or anterior resection (Procedure)
D3 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232, 231 and 253 will be removed.
For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and 253 and partially 241, 242 (considering variation of the feeding artery) will be removed.
For tumours in the mid part of sigmoid colon lymph nodes 241, 242 and 253 will be removed.
For tumours in the rectosigmoid junction 251, 252 and 253 groups of the lymph node will be removed.
干预措施: Left colon resection (Procedure)
D3 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232, 231 and 253 will be removed.
For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and 253 and partially 241, 242 (considering variation of the feeding artery) will be removed.
For tumours in the mid part of sigmoid colon lymph nodes 241, 242 and 253 will be removed.
For tumours in the rectosigmoid junction 251, 252 and 253 groups of the lymph node will be removed.
干预措施: Sigmoid colon resection (Procedure)
结局指标
主要结局
5-year overall survival
时间窗: Up to 5 years post-operatively
Probability to be alive measured in %, where 100% means that patients have a 100% probability to be alive and 0% means that patients have 0% probability to be alive
次要结局
- Early postoperative complications rate(1-30 days after surgery)
- Intraoperative complications rate(Day 0)
- Postoperative sexual dysfunction(Up to 1 year post-operatively)
- Apical lymph node involvement rate(1 month after surgery)
- Mortality(0-30 days after surgery)
- Late postoperative complications rate(30-180 days after surgery)
- 5-year disease free survival(Up to 5 years post-operatively)