Cirrhosis, Portal Hypertension
Conditions
Keywords
portal hypertension, portal pressure gradient, EUS interventions, Cirrhosis
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.
Interventions
DEVICEEUS-portal pressure gradient measurement (PPGM)
EUS-guided PPGM is performed under conscious sedation. An OGD would be performed to evaluate for findings consistent with portal hypertension such as varices and portal hypertensive gastropathy. 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. A pressure measurement is then obtained from the compact pressure transducer attached to the handle of the needle. Three separate measurements are made with re-priming of heparin (less than 0.5 ml). The process is repeated for the hepatic vein. 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Patients recruited to the study would receive measurement of the portal pressure gradient with the use of the EUS-guided technique
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 30 days | Ability to place a needle in the portal and hepatic vein for calculation of portal pressure gradient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 30 day | Any untoward event directly arising from the measurement of PPGM |
Countries
China
Contacts
CONTACTAnthony Y Teoh, FRCSEd
Outcome results
None listed