Lung Cancer Clinical Trial
Official title:
Effect of Post-Procedural Rapid Rollover on Pneumothorax After Percutaneous CT-Guided Lung Biopsy: A Randomized Controlled Trial
Pneumothorax is the most common complication after CT-guided lung biopsy, and several techniques have been proposed to reduce the risk. Among them, rapid rollover is the maneuver to immediately reposition the patient, with biopsy-side down after removal of biopsy needle. It has been theorized that the technique reduces the size of alveoli surrounding the needle tract, leading to airway closure and reduction in the alveolar-to-pleural pressure gradient, thereby preventing pneumothorax. The aim of this study is to evaluate the effectiveness of rapid rollover in reducing the risk of radiographically detectable pneumothorax and the rate of chest tube insertion. Patients undergoing CT-guided lung biopsy for any indication will be recruited and randomized into either rapid rollover group or control group. In the control group, CT guided lung biopsy will be performed per standard protocols; in the rapid rollover group, the biopsy will also be performed per the same protocol with the addition of rapid rollover at the end of the procedure. For both groups, the primary outcome would be new or enlarging pneumothorax detected on post-biopsy radiographs, and the secondary outcome would be the risk of pneumothorax necessitating chest tube insertion, all complications associated with CT guided lung biopsy, time to complication development, and patient experience in each arm.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | June 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients who are referred to the Department of Radiology and Biomedical Imaging Cardiac and Pulmonary Imaging section for CT-guided lung biopsy will be screened for eligibility. All eligible patients will be enrolled. Patients who develop intra-procedural pneumothorax will be analyzed but excluded from the final analysis. Exclusion Criteria: - Patients with chest wall, subpleural or mediastinal lesions - Patients who develop intra-procedural pneumothorax - Patients who are biopsied by a prone approach - Patients who are repositioned intra-procedurally - Patients who are unable to tolerate reposition or have spinal precautions - Patients who develop hemothorax and a chest tube is inserted for this indication |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
United States | Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiographically detectable pneumothorax | New or enlarging pneumothorax (from intraprocedural CT) which is detectable on post biopsy radiograph. The size of the pneumothorax will be measured in terms of the distance between visceral and parietal pleura. The severity of pneumothorax will be assessed using CTCAE 5.0. | 2 hours after biopsy | |
Secondary | Chest tube insertion | Pneumothorax that requires chest tube insertion or other operative interventions (or CTCAE 5.0 grade 2 and above). While the decision to intervene could be operator-dependent, chest tube insertion takes place at our institution for patients with 1) enlarging or symptomatic small pneumothorax, and 2) moderate pneumothorax regardless of symptoms. | 24 hours for overnight observation | |
Secondary | Enlarging pneumothorax | Enlarging pneumothorax from baseline pneumothorax > 3 mm (distance between visceral and parietal pleura measured on chest radiograph) accounting for redistribution of air and projection. | From 2 hours post biopsy to patient being discharged home. |
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