Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Biopsy Procedure.
NCT Number: NCT06484764
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Abdominal Cancer|Thoracic Cancer
Interventions: PROCEDURE: CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions|PROCEDURE: Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Collaborators: Tongji Hospital|The First Affiliated Hospital of Guangzhou Medical University|Wuhan United Imaging Healthcare-Surgical Technology Co., Ltd. Wuhan, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 166
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-07-03
Completion Date: 2023-11-24
Locations: First Clinical Affiliation of Guangzhou Medical University, Guangzhou, China|Tianjin Medical University Cancer Institute and Hospital, Tianjin, China|Tongji Hospital of Huazhong University of Science and Technology, Wuhan, China

Summary:
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:

1. Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure.
2. 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
3. Whether the robot-assisted needle biopsy method can decrease the patient's complication occurrence rate
4. 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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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., 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