Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry
NCT ID: NCT05817994
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-04-01
2023-04-01
Brief Summary
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Detailed Description
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This 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:
Upper endoscopy and Liver biopsy will benefit both the patients and the hospitals from completing both procedures in one setting.
Where 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Suspected liver disease based on abnormal liver function tests, standard ultrasound, transient elastography (Fibro Scan) or CT or MRI of the liver
* Planned upper endoscopy to evaluate for varices
* Planned liver biopsy based on suspected hepatitis or cirrhosis
Exclusion Criteria
* Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5)
* Inability to provide informed consent
ALL
Yes
Sponsors
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Boston Scientific Corporation
INDUSTRY
Sheikh Shakhbout Medical City
OTHER
Responsible Party
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References
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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.
Morales-Ruiz, Manuel, et al.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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313
Identifier Type: -
Identifier Source: org_study_id
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