Application and Translational Research of 3D Printed Models in the Surgical Treatment of Common Bile Duct Stones Under Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Surgery success rate
研究概览
简要总结
The goal of this clinical trial is to learn about Application and translational research of 3D printed models in the surgical treatment of common bile duct stones under endoscopic retrograde cholangiopancreatography. The main question it aims to answer are:Compare the differences in stone removal time, surgical complications, and surgical success rate during ERCP (+EST) surgery between 30 patients who used 3D printing preoperative simulation and 30 patients who did not use it.
Participating patients will be divided into two groups, one group of 30 patients will use 3D printed models for preoperative simulation planning and then undergo surgery, and the other group will undergo surgery directly without using 3D printed models.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple or single common bile duct stones (total stone diameter ≤1.5 cm)
- •Patients who voluntarily participated in the study and signed the consent form
排除标准
- •Patients with various underlying diseases, such as diabetes, coronary heart disease, and hypertension, that would increase the risk of surgery and affect the outcome of surgery
- •Patients who have had cholangiojejunostomy or Roux-en-Y anastomosis
- •Combined with intrahepatic bile duct stones require surgical treatment
结局指标
主要结局
Surgery success rate
时间窗: intraoperatively
The surgery success rate of the 3D printed model group was higher than that of the control group
operation time
时间窗: intraoperatively
The operation time of the 3D printed model group was shorter than that of the control group
amount of bleeding
时间窗: intraoperatively
The amount of bleeding of the 3D printed model group was lower than that of the control group
complications
时间窗: Within 3 days to 1 month after surgery
The complications of the 3D printed model group was lower than that of the control group
次要结局
未报告次要终点
研究者
Jiawei Qin
Resident physician
Guangdong Second Provincial General Hospital