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TBLC vs NIVATS in Interstitial Lung Disease
Sponsor: Rita Alexandra Afonso da Costa
Summary
Patients with suspected interstitial lung disease (ILD) may require a lung biopsy when clinical and imaging findings are inconclusive. This single-centre pilot study randomly assigns adults (1:1) to transbronchial lung cryobiopsy (TBLC) or to non-intubated video-assisted thoracoscopic surgical biopsy (NIVATS). Its main aims are to find out whether a larger trial is feasible (recruitment, acceptance of randomisation, completion of the assigned procedure, completeness of data) and to obtain preliminary estimates, with confidence intervals, of the diagnostic yield and the 30-day complication rate of each procedure. The study is not designed to demonstrate that one procedure is non-inferior or superior to the other; the results will be used to plan a multicentre confirmatory trial.
Official title: A Randomized Single-center Pilot Study Comparing Transbronchial Lung Cryobiopsy (TBLC) and Non-intubated Video-assisted Thoracoscopic Surgery (NIVATS) in Interstitial Lung Disease: Feasibility and Preliminary Estimates of Diagnostic Yield and Safety
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2026-11-02
Completion Date
2028-08
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
NIVATS biopsy
NIVATS is a surgical technique performed under the patient's spontaneous respiration without tracheal intubation. Patients are brought to the operating room and placed in the contralateral lateral decubitus position. The anesthesiologist initiates deep sedation combined with local infiltration at the incision site and an intercostal block guided by thoracoscopy or an erector spinae block guided by ultrasound. The lung biopsy is always performed using automatic stapling devices, sampling peripheral areas in two different lobes-usually on the right side, including the middle lobe. All patients leave the operating room with a digital chest drain, which allows for quantification of the air leak.
TBLC biopsy
TBLC is performed under general anesthesia with jet ventilation using a rigid bronchoscope (12 mm) as the main access route, through which a flexible bronchoscope is introduced. A 2.4 mm cryoprobe is used, along with real-time fluoroscopic guidance and a radial EBUS miniprobe to identify the target biopsy site. In selected cases, electromagnetic navigation can also be employed.Under fluoroscopic guidance, the cryoprobe is advanced to the selected segment until the pleural surface is reached, and then retracted 1 cm, with freezing times typically between 5 and 7 seconds. Following activation, the bronchoscope and cryoprobe are withdrawn together with the attached tissue sample.A total of 3 to 5 biopsies are generally performed per procedure, preferably from different segments within the same lobe, or different lobes from the same lung.
Locations (1)
Unidade Local de Saúde São João
Porto, Portugal