Cryoablation vs Thoracoscopic Surgery for GGN

Официальное название

Cryoablation Versus Thoracoscopic Surgery for Pulmonary Ground-Glass Nodules: A Prospective, Comparative, Open Label Study

Обзор

The aim of this study is to investigate the efficacy and safety of Cryoablation and Thoracoscopic Surgery in the treatment of pulmonary ground-glass nodules.

Подробное описание

The primary treatment for GGN type lung cancer is surgical resection, typically using video-assisted thoracoscopic surgery (VATS). Image-guided ablation therapy is considered as a treatment option for early-stage lung cancer patients unsuitable for surgery. It has been recommended by several guidelines as one of the curative treatment methods for primary lung cancer. Among various ablation techniques, cryoablation has the lowest complication rate. However, there is currently no research exploring whether cryoablation is not inferior to thoracoscopic surgery in terms of safety and efficacy in treating highly suspected malignant lung GGNs. This study is designed as a prospective, non-randomized study, with 160 patients expected to be enrolled, who will be assigned to cryoablation or video-assisted thoracoscopic surgery treatment groups based on patient preference. The primary endpoint is the 2-year disease-free survival. Secondary endpoints include 1-month mortality rate, overall survival, 5-year disease-free survival, local recurrence rate, VATS/ cryoablation completion rate, safety, etc.

Вмешательства

• Процедура Cryoablation
  The eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation.
• Процедура Thoracoscopic Surgery
  The eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery.

Первичные конечные точки

• 2-year disease-free survival [Срок оценки: Up to 2 years]

Вторичные конечные точки (10)

• 1-month mortality rate [Срок оценки: 1 month after the treatment]
• Overall survival [Срок оценки: Up to 2 years, 5years]
• 5-year disease-free survival [Срок оценки: Up to 5 years]
• Local recurrence rate [Срок оценки: Up to 5 years]
• VATS/ cryoablation completion rate [Срок оценки: immediately after the treatment]
• Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: 3 months after the treatment]
• Forced Vital Capacity (FVC) [Срок оценки: 3 months after the treatment]
• Adverse events and serious adverse events [Срок оценки: 3 months after the treatment]
• Quality of life assessment [Срок оценки: 1 week after the treatment]
• Length of hospital stay [Срок оценки: 1 month after the treatment]

Критерии участия

Критерии включения

• Patients ≥ 18 years old.
• The size of the GGN is 8-20mm (with less than 25% solid component), and the number of nodules requiring treatment in the short term is less than 3.
• Pathological confirmation of the GGN as non-small cell lung cancer; or progression of the GGN during at least 3 months of follow-up, including enlargement of the largest diameter, increase in solid component, or the appearance of a significant solid component in a previously pure GGN, with multidisciplinary discussion (including radiology, thoracic surgery, and pulmonology) suggesting malignancy.
• No lymph node, pulmonary, or distant metastasis to other organs.
• After multidisciplinary evaluation, the patient is considered capable of tolerating both surgical and ablation procedures.
• Unsuitable for radiation therapy or refusal of radiation therapy.
• Willing to participate in this clinical study and sign the informed consent form.

Критерии исключения

• Patients in poor general condition, with ECOG physical fitness score >2, unable to tolerate surgery or ablation therapy, or with relevant contraindications.
• Patients who have previously received other treatments for pulmonary GGNs.
• Patients with poor compliance.
• Severe heart, lung, kidney, brain, or other vital organ diseases.
• Active bacterial or fungal infections.
• Simultaneous or metachronous (within the past 5 years) double cancers.
• Women during pregnancy or breast-feeding.
• History of radiation therapy.
• Bleeding tendency, abnormal coagulation functions, or coagulation disorders that cannot be corrected after treatment.
• Contraindications to general anesthesia.
• Expected survival time < 6 months.
• The researcher believes that it is not suitable for inclusion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06848881 · SHCHE202501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗