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Trials / Recruiting

RecruitingNCT05597488

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
160 (estimated)
Sponsor
Chinese University of Hong Kong · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEUS guided portal pressure gradient measurementEUS-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.

Timeline

Start date
2022-11-01
Primary completion
2026-10-31
Completion
2026-10-31
First posted
2022-10-28
Last updated
2026-03-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05597488. Inclusion in this directory is not an endorsement.