EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EUS guided portal pressure gradient measurement.
- Who it may be relevant to
- Registry conditions: Cirrhosis Portal. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device EUS guided portal pressure gradient measurement
EUS-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
Primary outcome measures
- Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy [Time frame: 1 year]
Secondary outcome measures (1)
- Other outcome measurements [Time frame: 1 year]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT05597488 · 2022.088