Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-22 @ 5:31 AM
Study NCT ID:
NCT03804957
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2018-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized two arms single center'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2018-12-24', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Pneumothorax after biopsy', 'timeFrame': 'Immediately after lung puncture', 'description': 'Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray'}], 'secondaryOutcomes': [{'measure': 'Late Pneumothorax after biopsy', 'timeFrame': '2-6 hours', 'description': 'Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biopsy', 'pneumothorax'], 'conditions': ['Pneumothorax', 'Biopsy Wound']}, 'referencesModule': {'references': [{'pmid': '30480487', 'type': 'RESULT', 'citation': 'Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.'}, {'pmid': '28185770', 'type': 'RESULT', 'citation': 'Graffy P, Loomis SB, Pickhardt PJ, Lubner MG, Kitchin DR, Lee FT Jr, Hinshaw JL. Pulmonary Intraparenchymal Blood Patching Decreases the Rate of Pneumothorax-Related Complications following Percutaneous CT-Guided Needle Biopsy. J Vasc Interv Radiol. 2017 Apr;28(4):608-613.e1. doi: 10.1016/j.jvir.2016.12.1217. Epub 2017 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by autologous blood patch injection (ABPI).', 'detailedDescription': 'Pneumothorax is the most common complication of percutaneous lung biopsies. Reducing this risk is a goal of those who perform these procedures, particularly a reduction in large pneumothoraces requiring intervention (eg, pleural drainage) and hospitalization (Clayton et al. 2016). Recently, autologous blood patch injection (ABPI) inside the biopsy track has been suggested as an effective mean of sealing the punctured lung thus halting air loss and consequently pneumothorax (Graffy et al. 2017).\n\nThe aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by ABPI.\n\nIn particular, the main objectives are to compare:\n\n1. incidence of immediate pneumothorax\n2. incidence of late pneumothorax (2 hrs)\n3. incidence of chest tube placement\n4. duration of the procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'All patients scheduled for lung biopsy will be asked to join this study. After signing the informed consent the subject will be randomized for ABPI vs CNB approach.\n\nInclusion criteria:\n\n1\\) patients with pulmonary nodule requiring CT-guided lung biopsy.\n\nExclusion criteria:\n\n1. unfit for lung biopsy (INR \\>1.5, PLT \\<50.000, single lung);\n2. unavailable venous access.'}, 'identificationModule': {'nctId': 'NCT03804957', 'acronym': 'BloodyBiopsy', 'briefTitle': 'Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Clinical and Research Center'}, 'officialTitle': 'The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study', 'orgStudyIdInfo': {'id': 'ICH-BloodyBiopsy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CT-guided core needle biopsy (CNB)', 'description': '18 gauge ct-guided lung biopsy', 'interventionNames': ['Other: CT-guided core needle biopsy (CNB)']}, {'type': 'EXPERIMENTAL', 'label': 'CNB followed by ABPI.', 'description': '17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection', 'interventionNames': ['Other: Autologous blood patch injection (ABPI)']}], 'interventions': [{'name': 'Autologous blood patch injection (ABPI)', 'type': 'OTHER', 'description': 'Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy', 'armGroupLabels': ['CNB followed by ABPI.']}, {'name': 'CT-guided core needle biopsy (CNB)', 'type': 'OTHER', 'description': 'Standard 18g lung core biopsy', 'armGroupLabels': ['CT-guided core needle biopsy (CNB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'EZIO LANZA, MD', 'role': 'CONTACT', 'email': 'eziolanza@gmail.com', 'phone': '0282247383'}, {'name': 'FRANCESCA PICCOLI, MD', 'role': 'CONTACT', 'email': 'francesca.piccoli3@gmail.com'}], 'overallOfficials': [{'name': 'EZIO LANZA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital IRCCS, Rozzano-Milan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Clinical and Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}