Measuring portal pressure to predict treatment outcomes for varices in chronic hepatitis patients
EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
This study is trying to see if measuring portal pressure can help predict how well patients with chronic hepatitis and cirrhosis will respond to a treatment for swollen veins in the esophagus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT05597488 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether endoscopic ultrasound-guided portal-systemic pressure gradient measurement (EUS-PPGM) can predict the response to endoscopic variceal ligation (EVL) in patients with chronic hepatitis and cirrhosis. The researchers will measure portal pressure at three months post-treatment and correlate these values with the presence of varices requiring EVL during follow-up endoscopy after one year. The study focuses on patients who have undergone either primary or secondary variceal prophylaxis. By assessing these measurements, the study seeks to improve treatment strategies for managing varices in affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with chronic hepatitis-induced cirrhosis and esophageal varices who have received EVL.
Not a fit: Patients with advanced liver disease (Child-Pugh Class C), significant thrombocytopenia, or those with a history of hepatocellular carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction of treatment outcomes for patients with varices, potentially improving management strategies.
How similar studies have performed: While this approach is innovative, there is limited information on similar studies, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 to 75 years old * Informed consent available * Suffering from chronic hepatitis induced cirrhosis * Suffering from oesophageal varices and received EVL as a result of 1. Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or 2. Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding * Or bleeding gastric varices that have received endoscopic canoacrylate injection Exclusion Criteria: * Medical Child-Pugh Class C Uncorrected platelet count \<50,000 INR \> 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma * Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure). Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation \- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver. Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
Where this trial is running
Hong Kong, Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong, China (Recruiting)
Study contacts
- Study coordinator: Anthony Teoh
- Email: anthonyteoh@surgery.cuhk.edu.hk
- Phone: 852-35052956
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.