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

NCT07545057 | Not Yet Recruiting

• 1 other identifier: IS26059
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Biopsy diagnostic yield (at the lesion level)

  6 months

• Sensitivity of malignancy (at the lesion level)

  6 months

• Complete ablation rate (at the lesion level)

  3 months, 1 year, 2 years, 3 years, and 5 years

• Local progression-free period (at the lesion level)

  3 months, 1 year, 2 years, 3 years, and 5 years

• Progression-free survival

  3 months, 1 year, 2 years, 3 years, and 5 years

Study Arms (1)

Patients with clinically suspected malignant pulmonary nodules requiring diagnosis and treatment

EXPERIMENTAL

Procedure: Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules

Interventions

Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules PROCEDURE

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.

Patients with clinically suspected malignant pulmonary nodules requiring diagnosis and treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-021-22200000; xkyyjysun@163.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: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)