Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survival.
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer.
详细描述
The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio.
Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience.
Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group.
After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol.
Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT > 3).
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, Investigator)
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
- •At least 18 years of age.
- •ECOG status 0-
- •Histologically confirmed adenocarcinoma of the colon.
- •Clinical stage T1-3; N+; M
- •The physical status from ASA classification I, II, III or IV.
- •Written informed consent.
排除标准
- •Synchronous or metachronous malignancy.
- •Locally-advanced tumor (T>3).
- •Presence of distant metastases (M1).
- •Complicated tumor: obstruction, perforation.
- •Neoadjuvant chemotherapy.
- •Medical contraindications for surgical treatment.
- •Pregnancy or breast feeding.
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol.
结局指标
主要结局
Overall survival.
时间窗: 5 years after the last patient.
Overall survival of patients.
Disease-free survival.
时间窗: 5 years after the last patient.
Survival without local or distant recurrence.
次要结局
- Operation time.(Immediately after the surgery.)
- Number of days of inpatient treatment.(During hospitalization up to 4 weeks)
- Total number of metastatic lymph nodes and correlation by group.(Post-intervention at week 3.)
- Description of blood loss during the intraoperative period.(During the surgery.)
- Conversion.(During the surgery.)
- Postoperative morbidity.(The first 30 days after surgery.)
- Postoperative mortality.(The first 30 days after surgery.)
- Total number of lymph nodes removed.(Post-intervention at week 3.)
- Total length of removed bowel.(Post-intervention at week 3.)
- Area of mesentery removed.(Post-intervention at week 3.)