Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Biopsy Procedure.

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.

Conditions

• Abdominal Cancer
• Thoracic Cancer

Interventions

PROCEDURE

CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions

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.

PROCEDURE

Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions

Radiologists following the current clinical practice guidance to finish the freehand biopsy procedure under the CT guidance.

Sponsors & Collaborators

• Tongji Hospital

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Wuhan United Imaging Healthcare-Surgical Technology Co., Ltd. Wuhan, China

  collaborator UNKNOWN

• Tianjin Medical University Cancer Institute and Hospital

  lead OTHER

Principal Investigators

• Yu Haipeng, PhD,MD · Tianjin Medical University Cancer Institute and Hospital

• Nan Wang, PhD,MD · Tongji Hospital

• Bin Xiong, MD, PhD · First Clinical Affiliation of Guangzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-03

Primary Completion

2023-10-03

Completion

2023-11-24

Countries

• China

Study Locations