REGAL: Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

Sponsor

Sheikh Shakhbout Medical City (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05817994

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Liver Neoplasms Liver Dysfunction Liver Failure, Acute Liver Fibrosis Liver Inflammation

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Registry of Endoscopic Ultrasound Guided Assessment of the Liver (REGAL Study)

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Serious adverse events [30 days (Phase 1), 12 months (Phase 2)]
Serious adverse events related to all livery biopsy study procedures (Phase 1 and Phase 2)
LFTs abnormalities [from baseline to 6 months and from baseline to 12 months [Phase 2]]
Significant Changes in liver function lab tests
Noninvasive Liver Imaging abnormalities [from baseline to 6 months and from baseline to 12 months [Phase 2]]
Changes in 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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