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

NCT06484764 | Completed DMC

• 1 other identifier: ZRIR-003-22-01
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 3

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. 1.Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure.
2. 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. 3.Whether the robot-assisted needle biopsy method can decrease the patient's complication occurrence rate
4. 4.Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion.

Conditions

Abdominal Cancer; Thoracic Cancer

Keywords

Image guided biopsy; Robot-assisted method

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The number of needle adjustments

  The same day of the procedure

• Procedure time

  The same day of the procedure

• Puncture 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

Study Arms (2)

CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group

EXPERIMENTAL

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

Procedure: CT-fluoroscopy guided robot-assisted biopsy 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

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

Interventions

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.

CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group

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.

Freehand needle biopsy group under the CT guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Tongji Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Wuhan United Imaging Healthcare-Surgical Technology Co., Ltd. Wuhan, China: collaborator

Study Sites (3)

First Clinical Affiliation of Guangzhou Medical University

Guangzhou, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

Tongji Hospital of Huazhong University of Science and Technology

Wuhan, China

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: July 3, 2023
• Primary Completion: October 3, 2023
• Study Completion: November 24, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

CN (3)