NCT05291403

Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion

The Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined With Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion: a Multicenter, Prospective, Randomized, Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study intends to investigate the efficacy and safety of medical thoracoscopic cryotherapy combined with standard first-line treatment of advanced non-small cell lung cancer with malignant pleural effusion through a randomized controlled clinical trial.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer	Medical thoracoscopic cryotherapy: medical thoracoscopy biopsy hole insert bendable freezing probes, place the frozen probe placed in the center of the tumor at the top will be frozen carbon dioxide gas source pressure adjustment to the bar of 50-60 bar, tread down switch, foot pedal to start the probe, after about 30 s at the top of the probe to form a ice hockey, local tissue after frozen white, sometimes a small amount of bleeding; Fix the probe, loosen the pedal, and wait 30 seconds for automatic melting and rewarming (bleeding probability is low after full rewarming). Freeze 5 to 10 at a time. In addition, all patients were treated with standard first-line regimens according to guidelines of non small cell lung cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG) scores.
OTHER	Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer	The pleural effusion was fully drained and cisplatin 40mg/m2 was given, dissolved in 100mL 0.9% sodium chloride (NaCl) solution 100 mL, then injected into the pleural cavity and retained for 24 hours. Erythromycin was sequentially injected into the thorax to seal the pleural cavity. In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.
OTHER	Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment	Only intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated. In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.

Timeline

• Start date: 2022-04-06
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-03-22
• Last updated: 2023-11-18

Locations

1 site across 1 country: China