A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Abdominal Tumor Biopsy and Fiducial Marker Implantation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Accuracy of Angle
研究概览
简要总结
In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice.
In our previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for percutaneous biopsy of small pulmonary nodules. However, the accuracy of coplanar template assistance for abdominal tumor puncture are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of coplanar template assisted CT-guided abdominal tumor puncture during biopsy and fiducial markers implantation.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 85
- •Single or multiple abdominal tumors or mass (solid, partially solid)
- •Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
- •KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
- •Planned biopsy and/or fiducial marker implantation with applicable puncture path
- •With informed consent.
排除标准
- •Poor organ function (e.g. lung function FEV1<40% and/or DLCO<50%)
- •The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
- •Poor compliance, unable to complete coordination
- •Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
结局指标
主要结局
Accuracy of Angle
时间窗: during the operation
Angle (degree) difference between actual puncture and planned puncture pathway
Accuracy of Depth
时间窗: during the operation
Depth (millimeter) difference between actual puncture and planned puncture pathway
次要结局
- Complication rate(perioperative the operation)
- operating duration(during the operation)
- Success rate of needle puncture(during the operation)
- Number of CT scans(during the operation)
研究者
Qiu Bin
Principal Investigator
Peking University Third Hospital