Subsolid pulmonary nodule
Conditions
Interventions
Experimental group:Patients in the experimental group first undergo ablation of the accessory subsolid nodules located in the other ipsilateral lobes, followed 1–2 days later by surgical resection of
a core biopsy is obtained immediately before ablation for pathologic confirmation.
The ablative modalities include radiofrequency ablation, microwave ablation, or cryoablation. The multidisciplinary
Control group:Control-group patients undergo thoracoscopic anatomical lobectomy or segmentectomy of the dominant lesion, together with ipsilateral sublobar resection—segmentectomy or wedge resection—o
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Presence of multiple subsolid pulmonary nodules in different ipsilateral lobes requiring intervention: Based on imaging (with or without percutaneous biopsy) and after multidisciplinary discussion, the patient is determined to have synchronous subsolid nodules in two or more lobes of the same lung that are malignant or suspected malignant; all lesions are deemed to require loco-regional treatment. Nodule maximum diameter and consolidation-to-tumor ratio (CTR) serve as the principal criteria for distinguishing the dominant lesion from accessory lesions during multidisciplinary review. (2) Dominant subsolid nodule: maximum diameter 8 mm = R = 2 cm. (3) Accessory subsolid nodules: one to three additional nodules located in other ipsilateral lobes, each = 2 cm in maximum diameter, also scheduled for treatment. (4) Age 18–75 years. (5) ECOG performance status 0 or 1. (6) Pulmonary function: FEV1 = 80 % predicted and FEV1/FVC = 80 %. (7) Written informed consent obtained from the patient to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Presence of malignant or suspected-malignant solid pulmonary nodules, or any space-occupying lesion > 2 cm in greatest diameter. (2) Accessory lesions in different ipsilateral lobes that are deemed unsuitable for sublobar resection or ablation. (3) Evidence of regional lymph-node or distant metastasis on preoperative staging. (4) Suspected primary lung cancer with intrapulmonary metastasis. (5) Prior anticancer therapy—including chemotherapy, radiotherapy, immunotherapy, or targeted therapy—before enrollment. (6) Coexisting interstitial pneumonia, acute pulmonary infection, or pulmonary fibrosis. (7) Uncontrolled systemic comorbidities: refractory infection, severe cardiovascular or cerebrovascular disease, hepatic or renal dysfunction, poorly controlled diabetes, or other metabolic disorders. (8) History of any malignancy. (9) Trauma or surgery within the past 6 months. (10) Pregnancy, planned pregnancy, or lactation. (11) Psychiatric or psychological disorders. (12) Any other condition judged by the investigators to render the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year survival and overall survival;3-year recurrence rate and tumor free survival;Tumor ablation response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative quality of life;Treatment related complications;Postoperative pulmonary function; | — |
Countries
China
Contacts
Public ContactXiangnan Li
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed