MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI
详细描述
Our study design is a multicenter, prospective, registry study.
We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.
The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 ~ 50.5 Gy are recommended.
The postoperative examination should be performed every three months in the first two years and every six months in the following three years.
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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age between 18-75 years old
- •Pathologically confirmed as rectal adenocarcinoma
- •The tumor is located in the middle or lower rectum
- •Preoperative MRI assessment is T2-4 N+M0
- •Lateral lymph node short diameter ≥ 5 mm (MRI)
- •Signed informed consent
排除标准
- •Previous history of malignant colorectal tumors
- •Multiple abdominal or pelvic surgeries were performed
- •Complicated with bowel obstruction, perforation or bleeding
- •Patients undergoing palliative surgery
- •Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
- •Have a history of severe mental illness
- •Pregnant or breastfeeding women （8) Patients previously treated with iliac artery surgery (or its branches)
- •(9) R0 resection cannot complete (10) ASA grade ≥ IV
结局指标
主要结局
Overall survival rate
时间窗: 3-year
The proportion of patients survived after 3 years of surgery
Disease free survival
时间窗: 3-year
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.
Pathological positive rate
时间窗: 3-year.
The proportion of patients with positive lateral lymph node which was confirmed pathologically.
Local recurrence rate
时间窗: 3-year
The proportion of patients with local recurrence after 3 years of surgery
次要结局
- Early morbidity rate(30 days)
- Duration of the surgery(1 day)
- Postoperative complications(30 days)