EUS Guided Portal-systemic Pressure Gradient Measurement
- Conditions
- Portal HypertensionCirrhosis
- Interventions
- Device: EUS-portal pressure gradient measurement (PPGM)
- Registration Number
- NCT04633356
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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.
- Detailed Description
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. The technique involves ultrasound guided puncture of the internal jugular vein, followed by passage of a balloon catheter from through the right atrium, IVC and right hepatic vein. The free hepatic vein venous pressure is then measured followed by the wedge balloon venous pressure. The HVPG is then calculated by subtracting the free hepatic venous pressure from the wedge balloon venous pressure. When HVPG is \>10mmHg, the risk of developing varices is increased. If \>12mmHg, then risk of variceal bleeding is increased. Mortality risk is increased when HVPG is \>16-20mmHg. Nevertheless, the technique is technically difficult and it may not be available even in tertiary medical centres \[8\]. Furthermore, it requires the use of ionic contrast and also has a low acceptance rate amongst patients.
The aim of the current study is to investigate the feasibility of EUS-PPGM using the novel device and correlate the risk of developing complications with the PPGM in patients that are suffering from chronic hepatitis.
Recently, the use of EUS-guided approach for measurement of portal pressure gradient (PPGM) has been shown to be feasible. PPGM by the EUS approach was found to have excellent accuracy and strong correlation with pressure values obtained by the criterion standard transjugular wedged and free hepatic venous pressure measurements by interventional radiology in an animal model. Furthermore, in a pilot study involving 29 patients. 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. However, whether the technique could reproduce results similar to HVPG in humans is uncertain.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Suffering from chronic hepatitis induced cirrhosis
- Informed consent available
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EUS-portal pressure gradient measurement (PPGM) EUS-portal pressure gradient measurement (PPGM) All patients would receive measurement of PPGM using the study device
- Primary Outcome Measures
Name Time Method Technical success 30 days Ability to place a needle in the portal and hepatic vein for calculation of portal pressure gradient
- Secondary Outcome Measures
Name Time Method Adverse events 30 day Any untoward event directly arising from the measurement of PPGM
Trial Locations
- Locations (1)
Chinese University of Hong Kong
🇨🇳Hong Kong, Hong Kong, China