Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 495
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
详细描述
Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven rectal carcinoma.
- •Tumor located in the rectum.
- •Clinical Tis, T1, T2 N0 M0
- •Without multiple lesions other than carcinoma in situ
- •Tumor size <8 cm.
- •Sufficient organ function.
- •No bowel obstruction.
- •No history of major colorectal surgery.
- •No history of chemotherapy or radiotherapy.
- •Provide written informed consent.
排除标准
- •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- •Pregnant or lactating women.
- •Severe mental disease.
- •Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
- •Continuous systemic steroid therapy.
结局指标
主要结局
overall survival
时间窗: 5 year
次要结局
- anastomotic leakage rate(1 month)