Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT07249268
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-22', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the biopsy success rate', 'timeFrame': 'from enrollment to the end of the biopsy', 'description': 'the biopsy success rate of liver lesion'}], 'secondaryOutcomes': [{'measure': 'vasovagal reaction', 'timeFrame': 'during the procedure', 'description': 'A vasovagal reaction is a sudden drop in your heart rate and blood pressure. This reduces blood flow to your brain, which can cause you to feel dizzy, sweaty, and nauseous, and can sometimes lead to fainting.'}, {'measure': 'bleeding', 'timeFrame': 'during the procedure', 'description': 'bleeding due to biopsy'}, {'measure': 'pneumothorax', 'timeFrame': 'during the procedure', 'description': 'A pneumothorax (often called a collapsed lung) happens when air leaks into the space between your lung and your chest wall.'}, {'measure': 'shock', 'timeFrame': 'during the procedure', 'description': "Shock is a critical state of circulatory failure where the body's organs are starved of oxygen due to low blood flow, which can be caused by severe bleeding, heart failure, major infection, or a severe allergic reaction."}, {'measure': 'unplanned hospitalization', 'timeFrame': '48 hours after the surgery', 'description': 'An unplanned hospitalization is an urgent admission to a hospital, typically through the emergency department, for an unexpected and serious medical event or a sudden worsening of a pre-existing condition.'}, {'measure': 'death', 'timeFrame': '48 hours after the surgery', 'description': 'Death is the permanent and irreversible end of all life functions in a living organism.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Biopsy', 'Focal Liver Lesion', 'Coarse Needle Biopsy', 'Contrast-enhanced Ultrasound', 'Coaxial Biopsy'], 'conditions': ['Hepatic Lesions']}, 'descriptionModule': {'briefSummary': 'This study compared two methods used to guide needle biopsies of suspicious lumps (lesions) in the liver. A biopsy is a procedure where a small sample of tissue is taken to make a diagnosis. Doctors often use standard ultrasound (US) to see the lesion and guide the needle. Another method uses a special dye (contrast agent) injected into a vein during the ultrasound, which is called contrast-enhanced ultrasound (CEUS). The dye helps blood vessels and the lesion "light up" on the screen. The researchers wanted to find out if using CEUS leads to a more successful biopsy than using standard US alone.', 'detailedDescription': 'This study compared two different methods used to guide needles during a percutaneous (through the skin) biopsy of a focal liver lesion (a suspicious mass or lump in the liver). The goal was to see if one method was better than the other at ensuring a successful and diagnostic biopsy.\n\nThe researchers looked back at the records of 330 patients who had a liver biopsy. Of these, 113 had a CEUS-guided biopsy and 217 had a standard US-guided biopsy. To ensure a fair comparison, they used a statistical method to create two perfectly matched groups of 92 patients each. The patients in these groups were very similar in terms of factors like the size and location of their liver lesion, so that the only major difference was the type of guidance used (CEUS or US).\n\nFor most patients with a liver lesion that can be seen on a standard ultrasound, this study suggests that using the more advanced and expensive CEUS method does not increase the chances of a successful biopsy. The standard ultrasound guidance is just as effective.\n\nTherefore, the routine use of CEUS for all liver biopsies may not be necessary. This helps in managing healthcare resources wisely. However, CEUS remains a valuable tool for specific situations where a lesion is very difficult to see clearly on a standard ultrasound scan. Doctors can reserve CEUS for these more challenging cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent CEUS-guided or conventional US-guided coaxial biopsy for focal hepatic lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indeterminate liver lesions on prior imaging (CT/MRI).\n* Coaxial biopsy performed with 18G introducer needle.\n\nExclusion Criteria:\n\n* Coagulopathy (INR \\>1.5, platelets \\<50×109/L).\n* Contraindications to ultrasound contrast agents.'}, 'identificationModule': {'nctId': 'NCT07249268', 'briefTitle': 'Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions: A Propensity Score-Matched Analysis', 'orgStudyIdInfo': {'id': 'XMFHIIT-2025SL218'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CEUS Group', 'description': 'CEUS-guided coaxial biopsy for hepatic lesions', 'interventionNames': ['Procedure: CEUS or Contrast enhanced Ultrasound']}, {'label': 'US Group', 'description': 'US-guided coaxial biopsy for hepatic lesions', 'interventionNames': ['Procedure: US']}], 'interventions': [{'name': 'CEUS or Contrast enhanced Ultrasound', 'type': 'PROCEDURE', 'description': 'CEUS-guided coaxial biopsy for hepatic lesions', 'armGroupLabels': ['CEUS Group']}, {'name': 'US', 'type': 'PROCEDURE', 'description': 'US-guided coaxial biopsy for hepatic lesions', 'armGroupLabels': ['US Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Department of Ultrasound, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lijuan Yan', 'investigatorAffiliation': 'The First Affiliated Hospital of Xiamen University'}}}}