Hybrid Robot-Assisted Percutaneous Ablation and Non-Intubated VATS for Multiple Pulmonary Nodules

February 6, 2026 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

A Prospective Single-Arm Study Evaluating the Safety, Feasibility, and Perioperative Recovery of Robot-Assisted Percutaneous Ablation/Localization Combined With Non-Intubated Video-Assisted Thoracoscopic Surgery for Multiple Pulmonary Nodules

The goal of this clinical trial is to evaluate the safety and feasibility of a predefined hybrid treatment strategy in patients with multiple pulmonary nodules who require surgical management of at least one dominant lesion. The strategy combines robot-assisted CT-guided percutaneous ablation and/or localization with non-intubated video-assisted thoracoscopic surgery (NiVATS) performed during the same hospitalization.

The main questions this study aims to answer are:

Is the hybrid treatment strategy associated with an acceptable rate of perioperative serious complications?

Can the planned combination of robot-assisted percutaneous intervention and NiVATS be completed successfully in a real-world clinical setting?

Participants will:

Undergo preoperative evaluation and multidisciplinary assessment;

Receive robot-assisted CT-guided percutaneous ablation and/or localization for selected pulmonary nodules;

Undergo non-intubated video-assisted thoracoscopic surgery for resection of the dominant pulmonary lesion;

Be followed for perioperative outcomes and short-term recovery up to 30 days after surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm interventional study conducted at a tertiary academic medical center. The study enrolls adult patients with multiple pulmonary nodules, including at least one dominant lesion that meets standard indications for thoracoscopic surgical resection and one or more additional nodules for which complete surgical resection is considered undesirable due to concerns regarding lung parenchymal preservation or procedural risk.

All participants receive a predefined hybrid treatment strategy during the same hospitalization. Selected secondary pulmonary nodules are managed using robot-assisted CT-guided percutaneous procedures, including localization, biopsy, and/or thermal ablation as clinically appropriate. Subsequently, the dominant lesion is resected using non-intubated video-assisted thoracoscopic surgery under spontaneous ventilation anesthesia. Conversion to conventional intubated anesthesia is permitted if clinically indicated.

The primary focus of this study is to assess perioperative safety and technical feasibility rather than comparative efficacy. Safety is evaluated by monitoring perioperative complications within 30 days after the procedure, while feasibility is assessed based on successful completion of the planned hybrid treatment strategy. Secondary observations include perioperative recovery parameters such as length of hospital stay, postoperative pain, and short-term clinical outcomes.

This study is designed to provide prospective evidence regarding the clinical applicability of a hybrid, lung parenchyma-preserving approach for the management of multiple pulmonary nodules within the framework of current surgical and interventional practice.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • The First Affiliated Hospital of GZMU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 85 years at the time of enrollment.
  2. Presence of multiple pulmonary nodules identified on chest computed tomography (CT).
  3. At least one dominant pulmonary lesion meeting standard indications for thoracoscopic surgical resection based on radiologic assessment.
  4. At least one additional pulmonary nodule for which complete surgical resection is considered undesirable due to lung parenchyma preservation concerns or procedural risk, and deemed suitable for robot-assisted CT-guided percutaneous intervention.
  5. Determined by a multidisciplinary team (MDT) to be an appropriate candidate for the predefined hybrid treatment strategy.
  6. Eligible for non-intubated video-assisted thoracoscopic surgery based on preoperative anesthetic evaluation (ASA physical status I-III).
  7. Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  1. Pulmonary nodules located centrally or adjacent to major airways, major vessels, or the heart, where safe percutaneous intervention is not feasible.
  2. Pure ground-glass nodules with a maximum diameter < 6 mm, for which active surveillance is recommended.
  3. Clinical evidence of N1/N2 lymph node involvement or distant metastasis.
  4. Severe cardiopulmonary disease, interstitial lung disease, or other conditions that preclude thoracoscopic surgery or anesthesia.
  5. Coagulation disorders or ongoing anticoagulation therapy that cannot be safely discontinued.
  6. Pregnancy or breastfeeding.
  7. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid Robot-Assisted Percutaneous Intervention Plus Non-Intubated VATS
Participants in this single-arm study receive a predefined hybrid treatment strategy during the same hospitalization. The intervention consists of robot-assisted CT-guided percutaneous procedures (including localization, biopsy, and/or thermal ablation as clinically appropriate) for selected pulmonary nodules, followed by non-intubated video-assisted thoracoscopic surgery for resection of the dominant pulmonary lesion. Conversion to conventional intubated anesthesia is permitted if clinically indicated.
Procedure: Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery
This intervention consists of a predefined hybrid procedural strategy performed during the same hospitalization. Selected pulmonary nodules are managed using robot-assisted CT-guided percutaneous procedures, including localization, biopsy, and/or thermal ablation as clinically appropriate. Subsequently, the dominant pulmonary lesion is resected using non-intubated video-assisted thoracoscopic surgery under spontaneous ventilation anesthesia. Conversion to conventional intubated anesthesia is permitted if clinically indicated.
Other Names:
  • Robot-assisted percutaneous ablation
  • CT-guided percutaneous localization
  • Non-intubated VATS
  • NiVATS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Serious Complications
Time Frame: Within 30 days after the procedure
The proportion of participants who experience serious perioperative complications within 30 days after the procedure, defined as complications of Clavien-Dindo grade III or higher, including events requiring surgical, endoscopic, or radiologic intervention, intensive care management, or resulting in death.
Within 30 days after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful completion rate of the planned hybrid treatment strategy
Time Frame: From the start of the percutaneous intervention to completion of the planned hybrid procedure during the same hospitalization, assessed up to 30 days
Technical feasibility is defined as the proportion of participants in whom the planned hybrid treatment strategy-robot-assisted CT-guided percutaneous intervention followed by non-intubated video-assisted thoracoscopic surgery-is successfully completed without unplanned abandonment of the procedure. Conversion to conventional intubated anesthesia is permitted and will be recorded.
From the start of the percutaneous intervention to completion of the planned hybrid procedure during the same hospitalization, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZMUFAH-MLN-HYBRID-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in publications, including baseline characteristics, perioperative variables, and outcome measures, will be shared. No direct identifiers will be included. Data not relevant to the primary and secondary outcomes will not be shared.

IPD Sharing Time Frame

The IPD will be available beginning 6 months after publication of the primary study results and will be available for up to 3 years thereafter.

IPD Sharing Access Criteria

Access to the de-identified IPD will be granted to qualified researchers who provide a methodologically sound research proposal. Requests should be submitted to the principal investigator and will be reviewed by the study team. Approved researchers will be required to sign a data use agreement before access is granted. Data will be shared through secure data transfer methods.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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