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

NCT ID: NCT06484764

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-03
• Study Completion Date: 2023-11-24

Brief 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.

Detailed Description

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:

1. Lack of real-time and accurate information during the needle insertion process, including puncture force, needle deformation, soft tissue deformation, and needle arrival position;

2. 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.

3. 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.

4. The physiological trembling of the radiologist's hand will reduce the accuracy of puncture, and even lead to complications such as bleeding and pneumothorax

5. 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.

Conditions

Abdominal Cancer; Thoracic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group

Remote controlled, CT-fluoroscopy guided, robot-assisted biopsy procedure of thoracic and abdominal lesions

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Freehand needle biopsy group under the CT guidance

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Haipeng Yu

Professor, Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Haipeng, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Nan Wang, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Bin Xiong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Clinical Affiliation of Guangzhou Medical University

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

Countries

China

Other Identifiers

ZRIR-003-22-01

Identifier Type: -

Identifier Source: org_study_id