Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions
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|ClinicalTrials.gov Identifier: NCT02983903|
Recruitment Status : Terminated (Interim analysis also showed a lack of benefit in the experimental arm.)
First Posted : December 6, 2016
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solitary Pulmonary Nodule Multiple Pulmonary Nodules||Procedure: transbronchial biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Un-blinded, Intra-patient Comparison of Transbronchial Forceps Biopsy and Cryobiopsy for Peripheral Pulmonary Lesions|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||March 2, 2020|
|Actual Study Completion Date :||March 2, 2020|
Experimental: Single intervention arm - transbronchial biopsy
Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy
Procedure: transbronchial biopsy
- The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule. [ Time Frame: 1 year ]Sensitivity for cancer is defined as true positives / (true positives + false negatives) with respect to diagnosing malignancy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of any further, more invasive testing that is clinically indicated to evaluate the nodule.
- The increase in sensitivity for diagnosing a specific benign lung disease with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule. [ Time Frame: 1 year ]Sensitivity is defined as true positives / (true positives + false negatives) with respect to diagnosing a specific benign condition that is thought to represent the lung nodule seen on CT scan. If the bronchoscopic procedure fails to diagnose a specific benign condition, the gold standard will be the results of any further, more invasive testing and stable follow-up imaging at 1 year.
- The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy. [ Time Frame: 1 year ]A chest X-ray and ultrasound will be done to check for pneumothorax after standard forceps biopsy and after the addition of transbronchial cryobiopsy. Bleeding will be measured with a standardized scale (grade 0 = traces of blood not requiring suctioning; grade 1 = bleeding requiring suction to clear; grade 2 = bleeding requiring wedging of the biopsied segment with the flexible bronchoscope and/or iced saline/epinephrine; grade 3 = bleeding requiring further intervention such as balloon occlusion or inflation of the bronchial blocker; grade 4 = bleeding resulting in airway obstruction and acute hypoxemic respiratory failure, cardiopulmonary instability, transfusion of packed RBCs, and/or admission to the ICU) both after forceps biopsy and again after transbronchial cryobiopsy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983903
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||David M DiBardino, MD||University of Pennslyvania|