Robotic-Assisted Bronchoscopy-Guided Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules

A Feasibility Study on Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules Under Robotic-Assisted Bronchoscopy: A Prospective, Single-Arm, Open-Label Clinical Study：ROBUST Study

This is a prospective, single-arm, open-label clinical study. The primary study objective is to evaluate the feasibility of synchronous biopsy and radiofrequency ablation for pulmonary nodules under robotic-assisted bronchoscopy.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Nodules
• Intervention / Treatment: Procedure: Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-021-22200000; Email: xkyyjysun@163.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital
    • Contact: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-021-22200000; Email: xkyyjysun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old;
• Chest CT indicates pulmonary nodules, highly suspected of being malignant;
• Size of pulmonary nodules: 8 mm < maximum diameter ≤ 30 mm, and the number of pulmonary nodules requiring intervention ≤ 3;
• Preoperative imaging evaluation indicates no clear lymph node metastasis or distant metastasis (cT1N0M0);
• Multidisciplinary evaluation shows that the patient cannot tolerate surgery and radiotherapy, or the patient refuses surgery and radiotherapy after full informed consent;
• The patient understands and agrees to receive synchronous biopsy and ablation treatment under robotic-assisted bronchoscopy and signs a written informed consent form.

Exclusion Criteria:

• Patients who cannot tolerate general anesthesia due to advanced age or severe cardiopulmonary diseases, or other reasons;
• The target nodule has been diagnosed as a malignant tumor or metastasis;
• Patients with severe bleeding tendency or uncorrectable coagulation disorder (platelet count < 50×10^9 /L, prothrombin time > 18s, prothrombin activity < 40%);
• Severe pulmonary fibrosis and pulmonary hypertension;
• Anticoagulant or anti-platelet drugs have not been discontinued for the required time before surgery;
• Implanted cardiac pacemaker, defibrillator, or other electronic implants;
• Presence of important blood vessels that cannot be avoided along the biopsy path;
• Other conditions that the investigators consider not suitable for the patient to participate in this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with clinically suspected malignant pulmonary nodules requiring diagnosis and treatment

Procedure: Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules; All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. All procedures are performed under the guidance of shape-sensing robotic-assisted bronchoscopy integrated with mobile cone-beam computed tomography. Cyobiopsy is performed first using the 1.1-mm cryoprobe, followed by intraoperative frozen section for rapid diagnosis. If malignancy is confirmed, radiofrequency ablation is conducted in the same procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate (at the lesion level)	The proportion of lesions with a definite malignant diagnosis by synchronous biopsy and effective ablation (with postoperative immediate imaging indicating that the ablation range is at least 5 mm larger than the boundary of the target lesion) among the lesions ultimately diagnosed as malignant.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biopsy diagnostic yield (at the lesion level)	The proportion of lesions with a definite malignant or specific benign diagnosis by biopsy among all the lesions undergoing biopsy, evaluated by the pathological diagnosis.	6 months
Sensitivity of malignancy (at the lesion level)	The proportion of lesions with a definite malignant diagnosis by biopsy among all the lesions confirmed to be malignant by the gold standard of pathology, evaluated by the pathological diagnosis.	6 months
Complete ablation rate (at the lesion level)	The proportion of completely ablated lesions after ablation treatment among all the lesions undergoing ablation treatment, evaluated at 3 months, 1 year, 2 years, 3 years, and 5 years, respectively.	3 months, 1 year, 2 years, 3 years, and 5 years
Local progression-free period (at the lesion level)	The time from when the patient receives treatment until the target lesion shows local progression.	3 months, 1 year, 2 years, 3 years, and 5 years
Progression-free survival	The time from the patient receiving treatment until tumor progression or death from any cause (whichever occurs first).	3 months, 1 year, 2 years, 3 years, and 5 years
Overall survival	The time from the patient receiving treatment until death from any cause.	3 months, 1 year, 2 years, 3 years, and 5 years
Pulmonary function indicators (at the patient level)	The change level of indicators such as FEV₁ and DLCO 1 year after surgery compared with the preoperative baseline.	1 year
The incidence of procedure-related complications (at the patient level)	The incidence of device- or ablation-related adverse events during the operation and within 1 month after the operation, graded according to the CTCAE v6.0 criteria, with bleeding additionally evaluated using the Nashville Delphi (2020) scale.	1 month

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Study Director: Jiayuan Sun, MD, PhD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiofrequency Ablation
• Other Study ID Numbers: IS26059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No