Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Официальное название

Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial

Обзор

The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.

Подробное описание

This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.

Вмешательства

• Устройство The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
  Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
• Устройство The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
  Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.

Первичные конечные точки

• Complete ablation rate at 6 months after ablation [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Technical success rate [Срок оценки: Immediately after ablation]
• Complete ablation rate 12 months after ablation [Срок оценки: 12 months]
• Local control rate at 1 year, 2 years and 3 years after ablation [Срок оценки: 1 year, 2 years and 3years]
• Progression free survival (PFS) [Срок оценки: 3 years]
• Overall survival (OS) [Срок оценки: 3 years]
• Safety [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age greater than 18 years.
• Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
• The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
• Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.

Критерии исключения

• Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
• Patients with severe pulmonary fibrosis and pulmonary hypertension.
• Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
• Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
• Patients with poorly controlled malignant pleural effusion.
• Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation.
• Eastern Cooperative Oncology Group (ECOG) score > 2.
• Combined with other tumors with extensive metastasis, expected survival < 6 months.
• Patients with episodic psychosis.
• Patients with implantable electronic devices (such as pacemaker or defibrillator).
• Pregnant women, or patients who have pregnancy plans during the study.
• Participation or ongoing participation in another clinical study within the past 30 days.
• Other situations that the investigator deems inappropriate 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06052098 · BC-I-RF-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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