Safety and Efficacy Evaluation of Cryoablation in the Treatment of Ground-Glass Nodules

Официальное название

Safety and Efficacy Evaluation of Cryoablation for Ground-Glass Nodules: A Single-Arm, Prospective, Open-Label Clinical Study

Обзор

Lung cancer is the leading cause of cancer-related mortality worldwide, making early diagnosis and intervention critical. With the widespread adoption of low-dose computed tomography (LDCT) screening, the detection rate of pulmonary ground-glass nodules (GGNs) has increased significantly. Although video-assisted thoracoscopic surgery (VATS) remains the standard treatment for early-stage lung cancer, a considerable proportion of patients are ineligible for surgery due to advanced age, impaired cardiopulmonary function, or multiple nodules. Cryoablation, a minimally invasive ablation technique, uses ultra-low temperatures to induce tumor cell death. It offers distinct advantages, including well-defined ablation margins, reduced procedural pain, preservation of adjacent healthy structures, and potential immune activation, providing an important alternative for this patient population. However, the safety and long-term efficacy of cryoablation for GGNs require further high-quality clinical evidence. This study aims to conduct a prospective, single-center, open-label clinical trial to systematically evaluate the feasibility and outcomes of cryoablation (percutaneous or electromagnetic navigation bronchoscopy \[ENB\]-guided) for treating pulmonary GGNs. We plan to enroll 90 patients who meet the following criteria: pathologically or multidisciplinary team (MDT)-confirmed malignancy, GGN size ranging from 6-30 mm, solid component ratio \<25%, unsuitability for or refusal of surgery/radiotherapy, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The primary endpoint is the 2-year local recurrence rate after ablation. Secondary endpoints include the 5-year local recurrence rate, 3- and 5-year disease-free survival (DFS) rates, technical success rate (ablation completion), perioperative complications (e.g., pneumothorax, hemorrhage, infection), postoperative pulmonary function, pain scores, length of hospital stay, and treatment-related costs. The results of this study will provide critical clinical evidence to support the use of cryoablation for GGNs, optimize patient selection criteria, and promote the advancement of this minimally invasive technique.

Вмешательства

• Процедура Cryoablation
  Following enrollment, patients will undergo comprehensive preoperative evaluations, including thoracic computed tomography (CT), echocardiography, pulmonary function tests, electrocardiography, and laboratory blood tests, to confirm eligibility and exclude any contraindications. Eligible patients will be admitted for cryoablation, performed either percutaneously or under electromagnetic navigation bronchoscopy (ENB) guidance, followed by a structured postoperative follow-up regimen.

Первичные конечные точки

• 2-Year Local Recurrence Rate [Срок оценки: At 2 Years Post-Treatment]

Вторичные конечные точки (1)

• Technical Success Rate [Срок оценки: Perioperative]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Malignancy confirmed by histopathology or multidisciplinary team (MDT) discussion.

For a solitary GGN: size between 6-30 mm. For multiple GGNs: each measuring 6-30 mm, with no more than 3 nodules deemed to require treatment upon MDT consensus.

• Patient is ineligible for or unwilling to undergo video-assisted thoracoscopic surgery (VATS).
• Patient is ineligible for or declines radiotherapy or stereotactic body radiotherapy (SBRT).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The subject demonstrates good compliance and has voluntarily provided written informed consent to participate.

Критерии исключения

• Presence of severe cardiac, pulmonary, hepatic, or renal dysfunction, rendering the patient ineligible for general anesthesia.
• Contraindication to either bronchoscopy or computed tomography (CT)-guided percutaneous puncture.
• High risk associated with percutaneous puncture for at least one target lesion, or absence of a feasible access route as determined by pre-procedural bronchoscopic path planning.
• Platelet count < 50 × 10⁹/L, or presence of an uncorrectable bleeding diathesis or coagulation disorder (prothrombin time > 18 seconds, or prothrombin activity < 40%).
• Concurrent participation in another interventional clinical trial, or anticipation of requiring additional antitumor therapy outside the scope of this study during the trial period.
• Any other condition deemed by the investigator to render the patient unsuitable for study participation.

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 · 2 центра

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07232433 · RTS-027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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