Liver Diseases, Liver Dysfunction, Liver Failure, Acute, Liver Fibrosis, Liver Inflammation, Liver Neoplasms
Conditions
Keywords
liver, endoscopy, Biopsy, Ultrasound, EUS liver Biopsy
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Sheikh Shakhbout Medical City
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Adult (per local age threshold) * 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 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. * Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5) * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1] | 30 Days in 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 \[ Phase 1\] |
| Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 2] | 12 months in 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 \[ Phase 2\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse events | 30 days (Phase 1), 12 months (Phase 2) | Number of serious adverse events related to all livery biopsy study procedures (Phase 1 and Phase 2) |
| Number of Participants with Laboratory Abnormalities in Liver function Tests | from baseline to 6 months and from baseline to 12 months [Phase 2] | number of participants with abnormal levels of liver function tests |
| Number of Participants with Noninvasive Liver Imaging abnormalities | from baseline to 6 months and from baseline to 12 months [Phase 2] | number of participants with abnormal non-invasive liver imaging |
| Number of diagnostic liver biopsies | 13 months (phase 1 and 2) | Number of diagnostic liver biopsies in radiologically guided compared to the EUS-guided liver. biopsy (Phase 1 and Phase 2) |
Outcome results
None listed