Measuring portal pressure using endoscopic ultrasound in liver disease patients
Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
This study is testing if measuring portal pressure during an endoscopic ultrasound is a safe and helpful way to improve care for patients with liver disease who need a liver biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Methodist Health System Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06336850 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients with liver disease who are undergoing EUS-guided liver biopsies. Participants will have their portal pressure measured during the procedure to assess the adequacy and safety of this method. The study aims to provide insights into the effectiveness of PPGM in managing liver conditions. By focusing on patients referred for EUS-guided liver biopsy, the study seeks to enhance diagnostic capabilities in liver disease management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with a history of liver disease or suspected cirrhosis who are referred for EUS-guided liver biopsy.
Not a fit: Patients under 18 or over 85 years of age, pregnant or breastfeeding individuals, or those for whom endoscopic procedures are contraindicated may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the accuracy of liver disease assessments and enhance patient management strategies.
How similar studies have performed: While the specific approach of EUS-guided PPGM may be novel, similar studies using endoscopic ultrasound techniques have shown promise in other diagnostic applications.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * Age 18 years or older * Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy * History of liver disease or suspected cirrhosis and considered for PPGM EXCLUSION CRITERIA * Patient is less than 18 or greater than 85 years of age * Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study * Patient is unwilling or unable to sign and date the informed consent * Patient for whom endoscopic procedures are contraindicated.
Where this trial is running
Dallas, Texas
- Methodist Dallas Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Prashant Kedia, MD — The Methodist Hospital Research Institute
- Study coordinator: Crystee Cooper, DHEd
- Email: clinicalresearch@mhd.com
- Phone: 214-947-1280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.