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

RecruitingNAAges 18 Years - anyAllRuijin Hospital
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In plain words

What the trial is, and whether it could suit you

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. Howev

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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. Exclusion Criteria: * 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 ร— 10โน/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.
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What it tests

  • Cryoablation
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Where

2 sites
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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