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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05597488

Collaborator

(none)

160

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Portal	Device: EUS guided portal pressure gradient measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EUS guided portal pressure gradient measurement At index OGD, the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. After endoscopic treatment of varices, recruited patients would undergo 1st measurement of EUS-PPG within 10-14 days after index OGD. The patients would then be enrolled into a variceal surveillance program and be started on B-blockers if not already prescribed. The patients would then be scheduled for another follow-up OGD at 3 months with measurement of the 2nd EUS-PPG. Finally, a third follow-up OGD and EUS-PPG would be performed in 1-year after 1st EUS-PPG. Endoscopic findings attributed to chronic cirrhosis would be assessed in the 3 months and 1 year OGD and the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded.	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.

Arm

Intervention/Treatment

Experimental: EUS guided portal pressure gradient measurement

At index OGD, the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. After endoscopic treatment of varices, recruited patients would undergo 1st measurement of EUS-PPG within 10-14 days after index OGD. The patients would then be enrolled into a variceal surveillance program and be started on B-blockers if not already prescribed. The patients would then be scheduled for another follow-up OGD at 3 months with measurement of the 2nd EUS-PPG. Finally, a third follow-up OGD and EUS-PPG would be performed in 1-year after 1st EUS-PPG. Endoscopic findings attributed to chronic cirrhosis would be assessed in the 3 months and 1 year OGD and the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded.

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.

Outcome Measures

Primary Outcome Measures

Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy [1 year]
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.

Secondary Outcome Measures

Other outcome measurements [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anthony Teoh, Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05597488

Other Study ID Numbers:

2022.088

First Posted:

Oct 28, 2022

Last Update Posted:

Oct 28, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis

Hepatitis, Chronic

Study Results

No Results Posted as of Oct 28, 2022