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

NCT07395362 | Not Yet Recruiting

• 1 other identifier: GZMUFAH-MLN-HYBRID-2026-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Pulmonary Nodules

Keywords

Multiple pulmonary nodules; Ground-glass nodules; Robot-assisted percutaneous ablation; CT-guided intervention; Non-intubated video-assisted thoracoscopic surgery NiVATS

Outcome Measures

Primary Outcomes (1)

• Perioperative Serious Complications

  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 Outcomes (1)

• Successful completion rate of the planned hybrid treatment strategy

  From the start of the percutaneous intervention to completion of the planned hybrid procedure during the same hospitalization, assessed up to 30 days

Study Arms (1)

Hybrid Robot-Assisted Percutaneous Intervention Plus Non-Intubated VATS

EXPERIMENTAL

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

Interventions

Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery PROCEDURE

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.

Also known as: Robot-assisted percutaneous ablation, CT-guided percutaneous localization, Non-intubated VATS, NiVATS

Hybrid Robot-Assisted Percutaneous Intervention Plus Non-Intubated VATS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years at the time of enrollment.
• Presence of multiple pulmonary nodules identified on chest computed tomography (CT).
• At least one dominant pulmonary lesion meeting standard indications for thoracoscopic surgical resection based on radiologic assessment.
• 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.
• Determined by a multidisciplinary team (MDT) to be an appropriate candidate for the predefined hybrid treatment strategy.
• Eligible for non-intubated video-assisted thoracoscopic surgery based on preoperative anesthetic evaluation (ASA physical status I-III).
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of GZMU

Guangzhou, China

Location

Related Publications (3)

• Ye X, Fan W, Wang Z, Wang J, Wang H, Niu L, Fang Y, Gu S, Liu L, Liu B, Zhuang Y, Wei Z, Li X, Li X, Li Y, Li C, Yang X, Yang W, Yang P, Lin Z, Meng Z, Hu K, Liu C, Huang Y, Huang G, Huang K, Peng Z, Han Y, Jin Y, Lei G, Zhai B, Li H, Pan J, Filippiadis D, Kelekis A, Pua U, Futacsi B, Yumchinserchin N, Iezzi R, Tang A, Roy SH. Clinical practice guidelines on image-guided thermal ablation of primary and metastatic lung tumors (2022 edition). J Cancer Res Ther. 2022 Sep;18(5):1213-1230. doi: 10.4103/jcrt.jcrt_880_22.

  PMID: 36204866 RESULT

• Chen H, Kim AW, Hsin M, Shrager JB, Prosper AE, Wahidi MM, Wigle DA, Wu CC, Huang J, Yasufuku K, Henschke CI, Suzuki K, Tailor TD, Jones DR, Yanagawa J. The 2023 American Association for Thoracic Surgery (AATS) Expert Consensus Document: Management of subsolid lung nodules. J Thorac Cardiovasc Surg. 2024 Sep;168(3):631-647.e11. doi: 10.1016/j.jtcvs.2024.02.026. Epub 2024 Jun 14.

  PMID: 38878052 RESULT

• MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.

  PMID: 28240562 RESULT

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yudong Zhang, MD

CONTACT

+86 13168266675; yudongz834@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Thoracic Surgery

Model Details: This is a prospective, single-arm study in which all enrolled participants receive a predefined hybrid treatment strategy combining robot-assisted percutaneous intervention and non-intubated video-assisted thoracoscopic surgery during the same hospitalization.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 9, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

CN (1)