Chinese University of Hong Kong
Hong Kong, China
Location status: Recruiting
Location contact
Anthony Y Teoh, FRCSEd(Gen)
CONTACT
Anthony Y Teoh, FRCSEd(Gen)
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: 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.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
- Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or
- 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
Treatment and study plan
EUS guided portal pressure gradient measurement
DeviceEUS-guided PPGM is performed under monitored anaesthesia. The linear array echoendoscope is passed from the mouth into the stomach and duodenum, as with a standard exam. Under endoscopic ultrasound guidance, a 25 gauge EUS needle (Echotip, Cook Medical, USA) primed with heparin 100 USP/ml is then placed across the stomach or duodenal wall and through the liver parenchyma into the portal vein (Figure 3). A pressure measurement is then obtained from the compact pressure transducer attached to the handle of the needle (Figure 4). Three separate measurements are made with re-priming of heparin (less than 0.5 ml). The needle is then removed from the portal vein and liver, if necessary. The process is repeated for the hepatic vein (Figure 5). The EUS - PPG is calculated by subtracting the average of the three hepatic vein pressure measurements from the average of the 3 direct portal vein pressure measurements.
Primary outcomes
-
Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
Time frame: 1 year
The number of patients with a high EUS-PPGM at 3 months will be correlated with the presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy.
Secondary outcomes
-
Other outcome measurements
Time frame: 1 year
The value of Day 0, 3 months or 1year EUS-PPG would be correlated with the severity of cirrhosis, re-bleeding, number of sessions of repeated EVL and mortality at 1 year. Safety of the procedure would also be assessed as 30-day adverse events.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Chinese University of Hong Kong
Other
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Oct 28, 2022
- Registry last updated
- Mar 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.