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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Wuhan United Imaging Healthcare-Surgical Technology Co., Ltd. Wuhan, China | UNKNOWN |
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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group | Experimental | Remote controlled, CT-fluoroscopy guided, robot-assisted biopsy procedure of thoracic and abdominal lesions |
|
| Freehand needle biopsy group under the CT guidance | Active Comparator | Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions | Procedure | During the procedure, the participant first undergoes a CT scan the radiologist plans the needle trajectory based on the registered preoperative CECT (contrast-enhanced computed tomography ) and intraoperative CT. After the participant is manually sterilised and given local anaesthesia, the radiologist will remotely control the robot to finish the needle insertion process under the CT-fluoroscopy guidance and simultaneously adjust the angular needle if necessary. The radiologist confirms whether the needle has reached the target area by CT-fluoroscopy image. |
| Measure | Description | Time Frame |
|---|---|---|
| One-time puncture success rate | 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% | The same day of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The number of needle adjustments | The number will be counted when the needle tip angle was altered or needle retreat during puncture procedure. | The same day of the procedure |
| Procedure time | Time from the patient was positioned to the arrival at the target area that confirmed by CT imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Haipeng, PhD,MD | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Nan Wang, PhD,MD | Tongji Hospital | Principal Investigator |
| Bin Xiong, MD, PhD | First Clinical Affiliation of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Clinical Affiliation of Guangzhou Medical University | Guangzhou | China | ||||
| Tianjin Medical University Cancer Institute and Hospital |
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| Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions | Procedure | Radiologists following the current clinical practice guidance to finish the freehand biopsy procedure under the CT guidance. |
|
| The same day of the procedure |
| Puncture time | Time from the needle tip at the skin entry point to the puncture was completed. | The same day of the procedure |
| Radiation exposure dose to the patient | Total radiation dose received by patient during the procedure | The same day of the procedure |
| Complication rate | The proportion of patients with complications in the two groups. Complications including pneumothorax, pneumothorax, hemoptysis, bleeding and other adverse events. | Three days after the procedure |
| Tianjin |
| China |
| Tongji Hospital of Huazhong University of Science and Technology | Wuhan | China |