Hepatitis Clinical Trials

Find Hepatitis Clinical Trials Near You

EUS Guided Portal-systemic Pressure Gradient Measurement in Patients With Chronic Hepatitis.

Who is this study for? Adults with Portal Hypertension, Cirrhosis
What treatments are being studied? EUS-Portal Pressure Gradient Measurement (PPGM)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Suffering from chronic hepatitis induced cirrhosis

• Informed consent available

Locations
Other Locations
China
Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Anthony Y Teoh, FRCSEd
anthonyteoh@surgery.cuhk.edu.hk
35052956
Time Frame
Start Date: 2020-11-12
Estimated Completion Date: 2026-11-11
Participants
Target number of participants: 30
Treatments
Experimental: EUS-portal pressure gradient measurement (PPGM)
All patients would receive measurement of PPGM using the study device
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov