Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules

NCT06335563 | Recruiting

• 1 other identifier: STAR009
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.

Conditions

Pulmonary Nodule

Outcome Measures

Primary Outcomes (1)

• Accuracy of puncture localization of pulmonary nodules

  Quantified as the shortest distance from the actual position of the puncture needle tip to the originally planned puncture point

  Intraoperative

Secondary Outcomes (4)

• Success rate of puncture localization of pulmonary nodules

  Intraoperative

• Adjust the number of needle punctures

  Intraoperative

• Operating time

  Intraoperative

• Radiation dose

  Intraoperative

Study Arms (2)

AR glasses-assisted pulmonary nodule puncture localization

EXPERIMENTAL

Combined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.

Procedure: AR glasses-assisted pulmonary nodule puncture localization

CT-guided pulmonary nodule puncture localization

ACTIVE COMPARATOR

Positioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.

Procedure: CT-guided pulmonary nodule puncture localization

Interventions

AR glasses-assisted pulmonary nodule puncture localization PROCEDURE

Combined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.

AR glasses-assisted pulmonary nodule puncture localization

CT-guided pulmonary nodule puncture localization PROCEDURE

Positioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.

CT-guided pulmonary nodule puncture localization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80, no gender limit;
• Chest CT shows that the nodule involves the outer third of the lung and can be removed by wedge resection;
• Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
• Physical condition score ECOG 0-2 points;
• If you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician;
• Patients voluntarily participate and sign informed consent.

You may not qualify if:

• The lesion is located in front of the scapula, and the needle path is blocked;
• The distance between the center of the lesion and the top of the diaphragm is \< 3 cm;
• The lesion is adjacent to the hilus or large blood vessels;
• Pleural adhesions caused by a history of thoracotomy or pleural infection;
• The patient voluntarily withdraws midway.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Study Officials

• Deping Zhao, MD, PhD

  Shanghai Pulmonary Hospital, School of Medicine, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunlang She, MD

CONTACT

+86 17749739242; sylxan3344@163.com

Deping Zhao, MD, PhD

CONTACT

+86 13701816883; zdp1992@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrative Director of Thoracic Surgery Department

Model Details: AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary nodule puncture localizing group

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: March 14, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)