Clinical trial · Interventional
Hybrid Robot-Assisted Percutaneous Ablation and Non-Intubated VATS for Multiple Pulmonary Nodules
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hybrid Robot-Assisted Percutaneous Intervention Plus Non-Intubated VATS
- description
- 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.
- interventionNames
- Procedure: Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery
Primary outcomes (1)
- measure
- Perioperative Serious Complications
- timeFrame
- Within 30 days after the procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTYe 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
- RESULTChen 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
- RESULTMacMahon 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