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.
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. 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.
Study Type
OBSERVATIONAL
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1]
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 \[ Phase 1\]
Time frame: 30 Days in Phase 1
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 2]
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 \[ Phase 2\]
Time frame: 12 months in phase 2
Number of serious adverse events
Number of serious adverse events related to all livery biopsy study procedures (Phase 1 and Phase 2)
Time frame: 30 days (Phase 1), 12 months (Phase 2)
Number of Participants with Laboratory Abnormalities in Liver function Tests
number of participants with abnormal levels of liver function tests
Time frame: from baseline to 6 months and from baseline to 12 months [Phase 2]
Number of Participants with Noninvasive Liver Imaging abnormalities
number of participants with abnormal non-invasive liver imaging
Time frame: from baseline to 6 months and from baseline to 12 months [Phase 2]
Number of diagnostic liver biopsies
Number of diagnostic liver biopsies in radiologically guided compared to the EUS-guided liver. biopsy (Phase 1 and Phase 2)
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Time frame: 13 months (phase 1 and 2)