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Endoscopic ultrasound guided portal pressure measurement to predict the outcome of liver resection

Comparison of endoscopic ultrasound-guided portal pressure measurement and transjugular hepatic venous pressure gradient measurement as predictors of post-operative outcomes in patients undergoing abdominal surgery/liver resection.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000464864
Acronym
EUS PPGM
Enrollment
40
Registered
2021-04-20
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is looking for participants that are required to have abdominal surgery, liver resection, or liver transplantation. Portal hypertension is an increase in blood pressure in the portal vein; the blood vessel that carries blood within the gastrointestinal tract to the liver. Portal hypertension is a condition that is present in individuals with cirrhosis of the liver and other liver diseases, and assessing the degree of this condition is important for prognosis, risk evaluating, and to guide appropriate treatment. This is done by calculating a portal pressure measurement. The current gold standard for measuring portal hypertension is the ‘Transvenous technique’; however, this is a technically limiting procedure with potential complications, and may only provide indirect measurements of portal pressure. We aim to assess the safety and efficacy of measuring portal pressure via an ‘endoscopic ultrasound technique’ (EUS). Compared to the Transvenous approach, this method is new but is deemed relatively safer and more accurate. We are particularly interested in comparing the clinical outcomes of the two techniques, and to determine that the EUS approach for measuring portal hypertension is much more useful in predicting surgical and survival outcomes for liver disease patients. The study will not only determine the usefulness and safety profile of the EUS portal pressure measurement, but could also open up a whole new diagnostic approach for the majority of patients with liver diseases. We hypothesise that: (i) EUS technique for portal pressure measurement can predict clinical outcomes and survival in cirrhotic patients who undergo abdominal surgery, liver resection or liver transplant; and (ii) EUS technique for portal pressure measurement is safe and feasible.

Interventions

All subjects will have Endoscopic Ultrasound-guided Portal Pressure Gradient Measurement (EUS PPGM) and Transjugular Hepatic Venous Pressure Gradient (TJ-HVPG) assessment within 4 weeks of surgery. Procedural details as well as adverse events related to the procedures will be collected immediately after, 24 hours after and 7 days after the procedure. EUS-PPGM technique: The EUS-PPGM this will be performed by a gastroenterologist. Transjugular pressure gradient measurement will be performed by

All subjects will have Endoscopic Ultrasound-guided Portal Pressure Gradient Measurement (EUS PPGM) and Transjugular Hepatic Venous Pressure Gradient (TJ-HVPG) assessment within 4 weeks of surgery. Procedural details as well as adverse events related to the procedures will be collected immediately after, 24 hours after and 7 days after the procedure. EUS-PPGM technique: The EUS-PPGM this will be performed by a gastroenterologist. Transjugular pressure gradient measurement will be performed by a radiologist. - the duration of EUS-PPGM- measurement of hepatic vein will take about 8 minutes, measurement of portal vein approximately 8 minutes, procedure time 15 minutes including insertion of echoendoscope The apparatus for EUS-PPGM will comprise of a linear echoendoscope, a 25G FNA needle, and a compact manometer with non-compressible tubing (Cook Medical, Bloomington, IN). The tubing will be connected by a luer lock to the distal port of the manometer, while the heparinised saline will be connected to the proximal port. The end of the tubing is connected through a luer lock to the inlet of the 25G needle. First a forward viewing endoscope will be inserted to document any endoscopic evidence of varices (including size and presence of red wale marks) as well as portal hypertensive gastropathy. Prior to echoendoscope insertion, the manometer will be zeroed at the midaxillary line of the patient. The hepatic vein (HV) measurement will be conducted first. Doppler flow will be used to confirm the typical multiphasic waveform of hepatic venous flow. Using the 25G FNA needle, a transgastric transhepatic approach is used to puncture the HV. Approximately 1 mL of heparinised saline will be used to flush the needle which is visible on EUS to confirm good position within the vessel. After the initial rise in pressure reading as a result of flushing, the manometer reading will equilibrate at a steady pressure, which will then be measured three times. The mean of these three pressures is then considered the HV pressure. The FNA needle is then withdrawn from the vein into the liver parenchyma, and then back into the needle sheath. The needle tract within the liver parenchyma will be observed with Doppler flow on to ensure there is no flow within the needle tract. The portal vein (PV) measurement will conducted next. The umbilical portion of the left portal vein will be targeted, and Doppler flow will then be used to confirm the typical venous hum of portal venous flow. Using the 25G FNA needle, a transgastric transhepatic approach is used to puncture the PV. The procedure that follows is the same as what would have been performed for the HV. Three readings will be taken, the mean of which is considered the PV pressure. The patient is recovered in a similar manner to a routine diagnostic EUS with FNA, and postprocedural antibiotics are usually given for 5 days postprocedure. TJ HVPG measurement technique: We will use the standard technique. Under local anaesthesia and light sedation, a venous catheter introducer sheath will be placed in the right jugular vein, antecubital vein or femoral vein under ultrasound guidance using the Seldinger technique. Under fluoroscopy, a balloon-tipped catheter will be advanced into a main HV. The Free Hepatic Venous Pressure (FHVP) will then be measured with the tip of the catheter in the HV at 2 – 4 cm from its opening into the inferior vena cava. The balloon of the catheter will be inflated to occlude the HV, and occlusion will be confirmed by injection of 5 mL of contrast dye. The measurement of the WHVP will then follow. Each of the WHVP and FHVP measurements will be taken in triplicate, and the mean FHVP will be subtracted from the WHVP to calculate the HVPG. In terms of monitoring adherence to the intervention, this is only required during the procedure to ensure that it was performed. Procedural details are documented and any adverse events related to the procedures will be collected after 24 hours and 7 days after the procedure.

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1) Patients (with or without cirrhosis) who are recommended for liver resection or liver transplant 2) Patients with cirrhosis who are recommended to undergo abdominal surgery

Exclusion criteria

1) International Normalised Ratio (INR) > 1.6 2) Significant ascites 3) Child-Pugh C severity of cirrhosis 4) Presence of large gastric varices or periportal collateral vessels that prevent EUS approach to the hepatic and/or portal vasculature

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026