EUS Guided Portal-systemic Pressure Gradient Measurement
Recruiting · NCT04633356 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Portal hypertension is characterised by an increased portal pressure gradient (PPG), that is the difference in pressure between the portal vein and the inferior vena cava (IVC). Portal hypertension is a consequence of cirrhosis resulting from chronic hepatitis. Patients with portal hypertension are at risk of developing complications including oesophageal or gastric varices, variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy and mortality. Albeit its clinical significance, direct measurement of portal venous pressure to document portal hypertension has traditionally been difficult. The portal vein pressure can be measured by transhepatic or transvenous methods but the procedure carries a risk of intra-peritoneal bleeding. Furthermore, the IVC pressure measurement requires further transjugular catheterisation. Hence, the technique is rarely used. Currently, the gold standard in measurement of portal hypertension is via measurement hepatic venous pressure gradient (HVPG). The HVPG has been shown to correlate with risk of clinical decompensation, development of varices, hepatocellular carcinoma, variceal bleeding, spontaneous bacterial peritonitis and mortality. Nevertheless, the technique has a low acceptance rate amongst patients and it may not be available even in tertiary medical centres. Recently, the use of EUS-guided approach for measurement of portal pressure gradient (PPGM) has been shown to be feasible. The technical success rate was 100% and no adverse events were reported. Measurements obtained with the EUS approach was shown to correlate excellently with clinical parameters of portal hypertension including presence of varices, portal hypertensive gastropathy and thrombocytopenia. Furthermore, the procedure could be performed at the same time of screening oesophagogastroduodenoscopy (OGD), that is frequently required for variceal screening in this group of patients. Hence, the aim of the current study is to investigate the feasibility of EUS-PPGM and correlate the risk of developing complications with the PPGM in patients that are suffering from chronic hepatitis.
Who can take part
Inclusion criteria
- Suffering from chronic hepatitis induced cirrhosis
- Informed consent available
Exclusion criteria
- Medical
- Child-Pugh Class C
- Uncorrected platelet count \<50,000
- INR \> 1.5 (natural)
- Anatomical
- Previous transjugular intrahepatic or surgical portosystemic shunt
- 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
- Evidence of active GI bleeding (identified at screening and/or during the endoscopic procedure)
- If the volume of ascites in the path of the needle prevents apposition of the gastrointestinal tract and liver.
- Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers.
Where it is running
1 location listed.
- Chinese University of Hong Kong - Hong Kong, Hong Kong, China