EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Cirrhosis Portal Clinical Trial

Official title:

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597488
• Other study ID #: 2022.088
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Anthony Teoh
• Phone: 852-35052956
• Email: anthonyteoh[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 18 to 75 years old

• Informed consent available

• Suffering from chronic hepatitis induced cirrhosis

• Suffering from oesophageal varices and received EVL as a result of

1. Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or

2. Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding

• Or bleeding gastric varices that have received endoscopic canoacrylate injection

Exclusion Criteria:

• Medical Child-Pugh Class C Uncorrected platelet count <50,000 INR > 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma

• Anatomical Main 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 Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.

Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers

Related Conditions & MeSH terms

• Cirrhosis Portal
• Hepatitis
• Hepatitis, Chronic

Intervention

Device:
• EUS guided portal pressure gradient measurement
EUS-guided PPGM is performed under monitored anaesthesia. 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 (Figure 3). A pressure measurement is then obtained from the compact pressure transducer attached to the handle of the needle (Figure 4). Three separate measurements are made with re-priming of heparin (less than 0.5 ml). The needle is then removed from the portal vein and liver, if necessary. The process is repeated for the hepatic vein (Figure 5). 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.

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy	The number of patients with a high EUS-PPGM at 3 months will be correlated with the presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy.	1 year
Secondary	Other outcome measurements	The value of Day 0, 3 months or 1year EUS-PPG would be correlated with the severity of cirrhosis, re-bleeding, number of sessions of repeated EVL and mortality at 1 year. Safety of the procedure would also be assessed as 30-day adverse events.	1 year