NCT05817994

Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Sheikh Shakhbout Medical City · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Liver Diseases
• Liver Neoplasms
• Liver Dysfunction
• Liver Failure, Acute
• Liver Fibrosis
• Liver Inflammation

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2023-04-18
• Last updated: 2024-11-19