Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04633356
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EUS Guided Portal-systemic Pressure Gradient Measurement
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
EUS Guided Portal-systemic Pressure Gradient Measurement in Patients With Chronic Hepatitis.
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: