Randomized Multicenter Study Protocol: Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 主要终点
- R0 resection rate
研究概览
简要总结
The aim of this study is to assess the usefulness of a mathematical model of three-dimensional image process and reconstuction (3D-IPR) as a surgical planner in locally advanced colon cancer. In addition to comparing the diagnostic accuracy of this planner with that of the CT regarding the infiltration of neighbouring structures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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 of both sexes, aged ≥18 years.
- •Adenocarcinoma of the right, left, sigmoid and recto-sigmoid junction that have cT3 or cT4a/b according to the eighth TNM edition of the American Joint Committee on Cancer (AJCC). Pre-treatment diagnosis by imaging (CT) test.
- •Lymph node extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pretreatment diagnosis by imaging (CT) test.
- •Patients who access and sign informed consent for the surgical intervention.
排除标准
- •Suspected carcinomatosis on preoperative CT or intraoperative finding
- •Suspected distant metastasis on preoperative CT or intraoperative finding
- •Patients with tumors with infiltration considered to be unresectable (pre-surgical or intraoperatively), since the anatomical-pathological analysis will not be available.
研究组 & 干预措施
No 3D reconstruction group (Group A)
Group of patients in which 3D reconstruction is not going to be performed before surgery
3D Reconstruction Group (Group B)
Group of patients in which 3D reconstruction is going to be done before surgery
干预措施: 3D reconstruction (Diagnostic Test)
结局指标
主要结局
R0 resection rate
时间窗: 8 weeks
Proportion of patients achieving R0 resection (defined as microscopically margin-negative resection) following surgical planning with three-dimensional image post-processing reconstruction (3D-IPR) in patients with threatened surgical margins (TSM) in locally advanced colon cancer (LACC)
次要结局
- Rate of minimally invasive surgical approach(Within 8 Weeks)
- Conversion to open surgery(8 Weeks)
- Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity)(Within 8 Weeks)
- Overall survival (OS)(Up to 5 years)
- Rate of locoregional and distant recurrence(Up to 5 years)
- Rate of perioperative complications (Clavien-Dindo classification)(Within 30 days after surgery)