EUS Guided Portal-systemic Pressure Gradient Measurement

NCT04633356 | Recruiting Phase 1 FDA Device

• 1 other identifier: 2017.519
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension; Cirrhosis

Keywords

portal hypertension; portal pressure gradient; EUS interventions; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Technical success

  Ability to place a needle in the portal and hepatic vein for calculation of portal pressure gradient

  30 days

Secondary Outcomes (1)

• Adverse events

  30 day

Study Arms (1)

EUS-portal pressure gradient measurement (PPGM)

EXPERIMENTAL

All patients would receive measurement of PPGM using the study device

Device: EUS-portal pressure gradient measurement (PPGM)

Interventions

EUS-portal pressure gradient measurement (PPGM) DEVICE

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.

EUS-portal pressure gradient measurement (PPGM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffering from chronic hepatitis induced cirrhosis
• Informed consent available

You may not qualify if:

• 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
• Evidence of active GI bleeding (identified at screening and/or during the endoscopic procedure)
• If the volume of ascites in the path of the needle prevents apposition of the gastrointestinal tract and liver.
• Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong, China

RECRUITING

Related Publications (2)

• Huang JY, Samarasena JB, Tsujino T, Lee J, Hu KQ, McLaren CE, Chen WP, Chang KJ. EUS-guided portal pressure gradient measurement with a simple novel device: a human pilot study. Gastrointest Endosc. 2017 May;85(5):996-1001. doi: 10.1016/j.gie.2016.09.026. Epub 2016 Sep 29.

  PMID: 27693644 BACKGROUND

• Huang JY, Samarasena JB, Tsujino T, Chang KJ. EUS-guided portal pressure gradient measurement with a novel 25-gauge needle device versus standard transjugular approach: a comparison animal study. Gastrointest Endosc. 2016 Aug;84(2):358-62. doi: 10.1016/j.gie.2016.02.032. Epub 2016 Mar 3.

  PMID: 26945557 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anthony Y Teoh, FRCSEd

CONTACT

35052956; anthonyteoh@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients recruited to the study would receive measurement of the portal pressure gradient with the use of the EUS-guided technique

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: November 12, 2020
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)