Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

Trial Title: Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

NCT ID: NCT05817994

Condition: Liver Diseases
Liver Neoplasms
Liver Dysfunction
Liver Failure, Acute
Liver Fibrosis
Liver Inflammation

Conditions: Official terms:
Liver Neoplasms
Liver Diseases
Liver Failure
Liver Cirrhosis
Hepatitis
Liver Failure, Acute
Inflammation

Conditions: Keywords:
liver
endoscopy
Biopsy
Ultrasound
EUS liver Biopsy

Study type: Observational [Patient Registry]

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: April 2023

Completion date: July 2023

Lead sponsor:
Agency: Sheikh Shakhbout Medical City
Agency class: Other

Collaborator:
Agency: Boston Scientific Corporation
Agency class: Industry

Source: Sheikh Shakhbout Medical City

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05817994