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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Technical success rate (at the lesion level) [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Biopsy diagnostic yield (at the lesion level) [Срок оценки: 6 months]
• Sensitivity of malignancy (at the lesion level) [Срок оценки: 6 months]
• Complete ablation rate (at the lesion level) [Срок оценки: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Local progression-free period (at the lesion level) [Срок оценки: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Progression-free survival [Срок оценки: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Overall survival [Срок оценки: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Pulmonary function indicators (at the patient level) [Срок оценки: 1 year]
• The incidence of procedure-related complications (at the patient level) [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT07545057 · IS26059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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