NCT05597488 EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
| NCT ID | NCT05597488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Cirrhosis Portal |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-11-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05597488 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cirrhosis Portal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05597488 currently recruiting?
Yes, NCT05597488 is actively recruiting participants. Contact the research team at anthonyteoh@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT05597488 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT05597488 clinical trial?
NCT05597488 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 160 participants.