Validate the Feasibility and Safety of the Robot System by Comparing the CT-fluoroscopy Guidance Versus CT-guided Freehand Needle Biopsy in Participants With Suspected Thoracic or Abdominal Lesions in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 3
- 主要终点
- One-time puncture success rate
研究概览
简要总结
This multicenter, randomized controlled trial aims to investigate whether the interventional robot can be well and safely used for percutaneous needle biopsy compared with the freehand needle biopsy method under CT guidance in patients with suspected thoracic or abdominal lesions. The robot allows radiologists to remotely control the needle insertion process under the CT-fluoroscopy guidance. The main questions it aims to answer are:
- Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure.
- Whether the robot-assisted needle biopsy method can improve the success rate for radiologists to insert the needle into the target lesions area without additional needle adjustment
- Whether the robot-assisted needle biopsy method can decrease the patient's complication occurrence rate
- Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion.
All the participants with suspected thoracic and abdominal lesions will be randomly assigned to the study group or control group.
Participants in the study group will receive a robot-assisted biopsy procedure under the CT-fluoroscopy guidance.
Participants in the control group will receive a freehand needle biopsy under the CT guidance.
详细描述
Cancer has become the second main death reason among Chinese residents. According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 4.57 million new cases of cancer and more than 3 million deaths in China in 2020, accounting for 23.7% and 30.2% respectively of the total number of global cancer incidence and deaths in 2020. Early detection and early treatment have become crucial to reducing cancer incidence and mortality. Image-guided percutaneous needle biopsy has been an important and established method for tumour treatment and diagnosis. More specifically, physicians under CT, MRI (magnetic resonance imaging) or ultrasound guidance manually insert a puncture needle into the target area of the soft tissue lesion for biopsy. However, the image-guidance freehand biopsy method still faces the following challenges:
- Lack of real-time and accurate information during the needle insertion process, including puncture force, needle deformation, soft tissue deformation, and needle arrival position;
- Multiple scans during the puncture are needed to determine whether the needle has successfully reached the target area, which leads to prolonged operation time, easily induces complications and increases the radiation dose to the physicians.
- The accuracy of needle insertion is highly affected by the patient's respiration movement causing the multi-directional nonlinear displacement and deformation of tissues and organs (movement, rotation, etc.), resulting in the drift of the tumour position. Eventually, it is difficult for radiologists to insert the target position, resulting in false negative results of biopsy or procedure failure.
- The physiological trembling of the radiologist's hand will reduce the accuracy of puncture, and even lead to complications such as bleeding and pneumothorax
- Percutaneous puncture procedure is highly dependent on the ability and experience of radiologists.
Here, the investigators aim to evaluate whether the robot-assisted needle biopsy method can solve these challenges by comparing the safety and feasibility of robotic-assisted percutaneous needle biopsy with freehand needle biopsy.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Participants have suspected thoracic or abdomen lesions.
- •Participants need to receive CT-guided non-vascular percutaneous biopsy procedure
- •Lesion size ≥ 10 mm that confirmed by radiologists through the preoperative CT.
排除标准
- •Participants with uncorrectable coagulopathy, infectious lesions in the planned needle trajectory path, pulmonary echinococcosis considered on CT imaging, patients who need mechanical ventilation, hepatic alveolar echinococcosis, coma or other diseases that the investigators think not suitable for joining the study.
结局指标
主要结局
One-time puncture success rate
时间窗: The same day of the procedure
The criteria for successful one-time puncture were as follows: the operator judged that the needle had reached the target area without any needle withdrawal or needle direction change during the puncture time that from the needle tip penetrated the skin to the time that needle reached to the target area. The one-time puncture success rate = number of participants with one-time puncture success (study group or control group) / total number of subjects in the (study group or control group)\*100%
次要结局
- Procedure time(The same day of the procedure)
- Radiation exposure dose to the patient(The same day of the procedure)
- Complication rate(Three days after the procedure)
- The number of needle adjustments(The same day of the procedure)
- Puncture time(The same day of the procedure)
研究者
Haipeng Yu
Professor, Chief Physician
Tianjin Medical University Cancer Institute and Hospital