Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT05817994
Status:
WITHDRAWN
Last Update Posted:
2024-11-19
First Post:
2023-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'The study was withdrawn by the sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1]', 'timeFrame': '30 Days in Phase 1', 'description': 'Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 30 days after the first upper Endoscopy procedure on study \\[ Phase 1\\]'}, {'measure': 'Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 2]', 'timeFrame': '12 months in phase 2', 'description': 'Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 12 months after the first upper Endoscopy procedure on study \\[ Phase 2\\]'}], 'secondaryOutcomes': [{'measure': 'Number of serious adverse events', 'timeFrame': '30 days (Phase 1), 12 months (Phase 2)', 'description': 'Number of serious adverse events related to all livery biopsy study procedures (Phase 1 and Phase 2)'}, {'measure': 'Number of Participants with Laboratory Abnormalities in Liver function Tests', 'timeFrame': 'from baseline to 6 months and from baseline to 12 months [Phase 2]', 'description': 'number of participants with abnormal levels of liver function tests'}, {'measure': 'Number of Participants with Noninvasive Liver Imaging abnormalities', 'timeFrame': 'from baseline to 6 months and from baseline to 12 months [Phase 2]', 'description': 'number of participants with abnormal non-invasive liver imaging'}, {'measure': 'Number of diagnostic liver biopsies', 'timeFrame': '13 months (phase 1 and 2)', 'description': 'Number of diagnostic liver biopsies in radiologically guided compared to the EUS-guided liver.\n\nbiopsy (Phase 1 and Phase 2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver', 'endoscopy', 'Biopsy', 'Ultrasound', 'EUS liver Biopsy'], 'conditions': ['Liver Diseases', 'Liver Neoplasms', 'Liver Dysfunction', 'Liver Failure, Acute', 'Liver Fibrosis', 'Liver Inflammation']}, 'referencesModule': {'references': [{'pmid': '30266282', 'type': 'BACKGROUND', 'citation': 'Asrani SK, Devarbhavi H, Eaton J, Kamath PS. Burden of liver diseases in the world. J Hepatol. 2019 Jan;70(1):151-171. doi: 10.1016/j.jhep.2018.09.014. Epub 2018 Sep 26.'}, {'type': 'BACKGROUND', 'citation': 'Morales-Ruiz, Manuel, et al.'}, {'pmid': '33052529', 'type': 'BACKGROUND', 'citation': 'Baran B, Kale S, Patil P, Kannadath B, Ramireddy S, Badillo R, DaVee RT, Thosani N. Endoscopic ultrasound-guided parenchymal liver biopsy: a systematic review and meta-analysis. Surg Endosc. 2021 Oct;35(10):5546-5557. doi: 10.1007/s00464-020-08053-x. Epub 2020 Oct 14.'}, {'pmid': '32141043', 'type': 'BACKGROUND', 'citation': 'Ali AH, Panchal S, Rao DS, Gan Y, Al-Juboori A, Samiullah S, Ibdah JA, Hammoud GM. The efficacy and safety of endoscopic ultrasound-guided liver biopsy versus percutaneous liver biopsy in patients with chronic liver disease: a retrospective single-center study. J Ultrasound. 2020 Jun;23(2):157-167. doi: 10.1007/s40477-020-00436-z. Epub 2020 Mar 5.'}, {'pmid': '33766911', 'type': 'BACKGROUND', 'citation': 'Bang JY, Ward TJ, Guirguis S, Krall K, Contreras F, Jhala N, Navaneethan U, Hawes RH, Varadarajulu S. Radiology-guided percutaneous approach is superior to EUS for performing liver biopsies. Gut. 2021 Dec;70(12):2224-2226. doi: 10.1136/gutjnl-2021-324495. Epub 2021 Mar 25. No abstract available.'}, {'pmid': '28320514', 'type': 'BACKGROUND', 'citation': 'ASGE Technology Committee; Trikudanathan G, Pannala R, Bhutani MS, Melson J, Navaneethan U, Parsi MA, Thosani N, Trindade AJ, Watson RR, Maple JT. EUS-guided portal vein interventions. Gastrointest Endosc. 2017 May;85(5):883-888. doi: 10.1016/j.gie.2017.02.019. Epub 2017 Mar 18. No abstract available.'}, {'pmid': '29874904', 'type': 'BACKGROUND', 'citation': 'Samarasena JB, Chang KJ. Endoscopic Ultrasound-Guided Portal Pressure Measurement and Interventions. Clin Endosc. 2018 May;51(3):222-228. doi: 10.5946/ce.2018.079. Epub 2018 May 31.'}, {'pmid': '27693644', 'type': 'BACKGROUND', 'citation': 'Huang JY, Samarasena JB, Tsujino T, Lee J, Hu KQ, McLaren CE, Chen WP, Chang KJ. EUS-guided portal pressure gradient measurement with a simple novel device: a human pilot study. Gastrointest Endosc. 2017 May;85(5):996-1001. doi: 10.1016/j.gie.2016.09.026. Epub 2016 Sep 29.'}, {'pmid': '20189503', 'type': 'BACKGROUND', 'citation': 'Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Patient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic\\_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.', 'detailedDescription': 'The finding of this patient Registry may lead to recommendations towards optimizing liver biopsy procedures. If the study demonstrates the optimization of the number of interventions needed to reach diagnostic and therapeutic goals in the setting of suspected liver disease thanks to the utilization of Acquire compared to other liver biopsy procedures, this data can be used as part of economic messaging of the BSC Acquire Fine Needle Biopsy.\n\nThis Registry will document all relevant diagnostic and therapeutic radiologic - trans jugular or percutaneous - and endoscopic/endosonographic interventions which enrolled patients undergo when they are suspected to have liver disease and are indicated for an endoscopic procedure and liver biopsy. The study will help illustrate that an EUS guided approach for liver biopsy in patients with suspected liver disease that is indicated for:\n\nUpper endoscopy and Liver biopsy will benefit both the patients and the hospitals from completing both procedures in one setting.\n\nWhere possible, the proposed Registry will also allow for the dynamic assessment of the severity of liver disease and for monitoring of changes to therapy for liver fibrosis and/ or portal hypertension. It is anticipated that the ability to monitor changes in liver status over time will become increasingly important as new therapies emerge in the field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll patients with suspected liver disease that are indicated for upper endoscopy for the assessment for esophageal varices and liver biopsy as per the local standard of care.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (per local age threshold)\n* Suspected liver disease based on abnormal liver function tests, standard ultrasound, transient elastography (Fibro Scan) or CT or MRI of the liver\n* Planned upper endoscopy to evaluate for varices\n* Planned liver biopsy based on suspected hepatitis or cirrhosis\n\nExclusion Criteria:\n\n* Severe Coagulation/bleeding disorder as defined by INR \\> 2 IU which cannot be corrected with FFP or Platelets \\< 50,000 per microliter which cannot be corrected with platelet transfusion.\n* Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5)\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05817994', 'acronym': 'REGAL', 'briefTitle': 'Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry', 'organization': {'class': 'OTHER', 'fullName': 'Sheikh Shakhbout Medical City'}, 'officialTitle': 'Registry of Endoscopic Ultrasound Guided Assessment of the Liver (REGAL Study)', 'orgStudyIdInfo': {'id': '313'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheikh Shakhbout Medical City', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}