Development of dual-function semi-rigid thoracoscopy and initial clinical testing
Mingming Deng, Ziwen Zheng, Run Tong, Jia Li, Liwei Liao, Yiding Bian, Gang HouAbstract
Background and Objectives
Medical thoracoscopy included semi-rigid and rigid thoroscopies, plays an important role in the diagnosis and treatment of pleural diseases. To combine the best features of the semi-rigid and rigid thoroscopies, we designed and developed a dual-function semi-rigid thoracoscopy with a straight working channel and a semi-rigid forceps. This study evaluated the accessibility, diagnostic yield, and safety of these novel devices.
Methods
Accessibility in the pleural cavity was evaluated using a standard thoracic model. Using a porcine model, we compared the dual-function semi-rigid thoracoscopy with semi-rigid forceps and semi-rigid thoracoscopy with flexible forceps for sampling quality and safety. Consecutive 12 patients with unknown unilateral pleural effusion and a negative or unsuccessful pleural fluid aspirate received standard pleural biopsy protocol via dual-function semi-rigid thoracoscopy with both semi-rigid and flexible forceps. Final diagnoses, sampling size and depth, and the adverse events were recorded.
Results
The accessibility of the dual-function semi-rigid thoracoscope in the pleural cavity was comparable to that of the semi-rigid thoracoscope. The semi-rigid forceps yielded larger and deeper specimens than those obtained via flexible forceps, both in healthy porcine and patients. Additionally, overall diagnostic yield of semi-rigid forceps was higher than that of flexible forceps without statistical significance (91.7% vs. 75.0%, P = 0.248).
Conclusion
Dual-function semi-rigid thoracoscopy with semi-rigid forceps maintains the same accessibility as semi-rigid thoracoscopy, while showing a trend of higher physical quality of the biopsy (size and depth) than that of flexible forceps. Further RCTs are needed to validate its potential diagnostic yield and safety compared with traditional semi-rigid and rigid thoroscopies.