Efficacy and safety of medical thoracoscopic bullous reduction surgery for chronic obstructive pulmonary disease with giant bullae: a prospective, randomized, controlled, multicenter, open-label study.

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: control group:Standard treatment for chronic obstructive pulmonary disease (based on GOLD guidelines);experimental group:Medical thoracoscopic reduction of volume in giant pulmonary bullae combined with standard treatment; CONDITION: Chronic obstructive pulmonary disease with giant bullae PRIMARY OUTCOME: The change in forced expiratory volume in one second (FEV1) from baseline at 6 months after randomization.; SECONDARY OUTCOME: The incidence of various complications, such as the amount and incidence of intrapleural hemorrhage; the incidence of pleural reaction; the degree and extent of procedure‐related pain; and the rate of;Changes in 6‐minute walk distance at 6 and 12 months after randomization;Changes in the Modified Medical Research Council Dyspnea Questionnaire (mMRC), the COPD Patient Self‐Assessment Test (CAT), and the St. George's Respiratory Questionnaire (SGRQ) scores before and afte; INCLUSION CRITERIA: 1. Sign the informed consent form approved by the Integrity Review Board (IRB); 2. Be able to understand the study content and sign the written informed consent form, agreeing to complete all visits and assessments specified in the protocol; 3. Age 40‐80 years; 4. BMI 18.5‐35 kg/m^2; 5. Diagnosed with COPD according to the GOLD 2025 criteria (FEV1/FVC < 0.70 after inhalation of bronchodilators; bronchodilator test record within 1 year prior to screening); 6. Chest high‐resolution CT (HRCT) preliminarily meets the GBE criteria; 7. Have received SoC treatment according to the GOLD 2025 ABE group for >= 12 months prior to enrollment and the regimen is stable; 8. Quit smoking for >= 4 months prior to screening and agree not to smoke (including e‐cigarettes) during the screening period.
Epistemonikos ID: e2f6286e7721d826146895470a009a7e3bd3ca64
First added on: Oct 08, 2026