Application of 3D Printing in Laparoscopic Surgery of Liver Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Blood loss
研究概览
简要总结
To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.
详细描述
Project goal is to evaluate utility of personalized 3D printed models in preoperative planning and performing laparoscopic liver resections. Models will be developed with unique, low-cost approach. Project will consist of three overlapping modules/stages evaluating:
- Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering
- Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan
- Whether 3D printed models utilized in planning and navigating laparoscopic resections affect perioperative outcomes
Methodology of developing 3D models is described elsewhere. Printed models will be delivered to surgical team at least 5 days prior to the resection. Surgery will be performed in both arms according to the department's procedures and surgical oncology guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age over 18
- •Patient qualified to undergo liver tumor resection (either primary of metastatic; both benign and malignant lesions)
- •Quality of imaging (CT or MRI or PET (positron emission tomography)/CT) satisfactory to develop 3D models
- •Laparoscopic approach
- •Informed consent
排除标准
- •Open approach
- •Technical limitations to model development
- •No informed consent
结局指标
主要结局
Blood loss
时间窗: intraoperative
Operative time
时间窗: intraoperative
Number of changes in surgery plan
时间窗: intraoperative
次要结局
- Length of stay(until patient discharge, an average of 7 days)
- Mortality(90 days)
- Complications(intraoperative and until discharge, an average of 7 days)
- Conversion rate(intraoperative)
- Readmissions(6 months)
研究者
Jan Witowski
Principal Investigator
Jagiellonian University