Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry (REGAL)

November 14, 2024 updated by: Sheikh Shakhbout Medical City

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

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1]
Time Frame: 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]
30 Days in Phase 1
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 2]
Time Frame: 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]
12 months in phase 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of diagnostic liver biopsies
Time Frame: 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)
13 months (phase 1 and 2)
Number of serious adverse events
Time Frame: 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)
30 days (Phase 1), 12 months (Phase 2)
Number of Participants with Laboratory Abnormalities in Liver function Tests
Time Frame: from baseline to 6 months and from baseline to 12 months [Phase 2]
number of participants with abnormal levels of liver function tests
from baseline to 6 months and from baseline to 12 months [Phase 2]
Number of Participants with Noninvasive Liver Imaging abnormalities
Time Frame: from baseline to 6 months and from baseline to 12 months [Phase 2]
number of participants with abnormal non-invasive liver imaging
from baseline to 6 months and from baseline to 12 months [Phase 2]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Shakhbout Medical City

Collaborators

Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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