The primary study objective is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® systemic Pressure Gradient (EchoTip® InsightTM) and…
ID
Source
Brief title
Condition
- Other condition
- Hepatic and hepatobiliary disorders
Synonym
Health condition
liver cirrhosis, portal hypertension
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary measure is the evaluation of the correlation between the calculated
PPG obtained using the EchoTip® Insight and the HVPG procedure performed under
general anesthesia.
Secondary outcome
The secondary measures are:
1. Comparison between calculated PPG obtained by EchoTip® Insight and mild
sedation HVPG
2. HVPG measurement performed under mild sedation compared to the HVPG
measurement under general anesthesia
3. Direct portal vein pressure measurement obtained by the EchoTip® Insight
compared to the transjugular WHVP measurement obtained during an IR
(Interventional Radiology) procedure under mild sedation and general anesthesia
4. Direct hepatic vein pressure measurement obtained by the EchoTip® Insight
compared to the transjugular FHVP measurement obtained during an IR procedure
under mild sedation and general anesthesia
5. Evaluation of technical success (see Definitions section in the protocol)
6. Evaluation of the association between EchoTip® insight measurements and the
degree of clinical features of portal hypertension. At minimum, the following
will be evaluated to determine whether there is clinical significance between
EchoTip® Insight measurements and HVPG measurements and clinical presentation
including:
a. Presence of gastric or esophageal varices
b. Portal hypertensive gastropathy
c. Thrombocytopenia
d. Child-Pugh score
e. MELD score
f. Liver elasticity (if available within 1 year prior to procedure)
7. All EchoTip® -related adverse events (see Definitions section in the
protocol)
For patients receiving a transjugular intrahepatic portosystemic shunt (TIPS)
(see Definitions section in the protocol) only:
8. Direct portal vein pressure measurement obtained by the EchoTip® insight
compared to the transjugular direct portal vein measurement obtained during an
IR procedure (only in patients undergoing a TIPS procedure)
Background summary
Measurements of the venous blood pressure in the liver provides the study
doctor with important clinical information to develop a treatment plan for
patients diagnosed with cirrhosis. The conventional method for measurement of
vascular blood pressure in the liver is HVPG, where direct free (FHVP) and
wedged (WHVP) hepatic vein pressure measurements are obtained. However, HVPG
provides an indirect measurement and can be burdensome to the patient. The
EchoTip® Insight* device provides a direct measurement of the vascular blood
pressure in the liver and can be less burdensome for the patient.
Study objective
The primary study objective is to evaluate the correlation of the calculated
portosystemic pressure gradient (PPG) obtained by direct portal and hepatic
pressure measurements with the EchoTip® systemic Pressure Gradient (EchoTip®
InsightTM) and indirect portal vein pressure measurements using the
interventional radiology based hepatic venous pressure gradient (HVPG)
procedure where direct free (FHVP) and wedged (WHVP) hepatic vein pressure
measurements are obtained.
Study design
The study is an international, multicenter, prospective, clinical post-market
study.
Intervention
See also pages 28-30 of the protocol and schedule in the protocol on page 12.
Non-TIPS patients
1. Mild sedation: To control for possible variations in portal pressure due to
the influence of anesthetic agents, a first set of HVPG measurements will be
undertaken under mild sedation in accordance with standard of care. During the
HVPG procedure, HVPG will be calculated, using standard balloon occlusion
measurement techniques, as is the standard of care for this procedure (FHVP and
WHVP each in triplicate).
2. General anesthesia: After this first set of measurements, the patient will
receive propofol general anesthesia, which will be maintained by an
anesthesiologist throughout the procedure. The patient will be intubated and
mechanically ventilated.
3. Concomitantly, the EchoTip® Insight and HVPG measurements will begin. The
EchoTip® Insight measurements are performed as described below by the endoscopy
physician. This will be coordinated with the center's IR (Interventional
Radiology) department performing the HVPG procedure. The physician performing
HVPG and the endoscopy physician performing EchoTip® measurements will be
strongly encouraged not to share results taken by the other physician. If
possible, the hepatic vein pressure measurements using both the techniques
should be obtained within the same hepatic vein.
The endoscopy physician will begin the EchoTip® Portosystemic Pressure Gradient
measurement (the study procedure see Definitions) in conjunction with the HVPG
measurements performed by the IR physician.
a. First, an esophagogastroduodenoscopy and an EUS will be performed to
evaluate for exclusion criteria. If no exclusion criteria are met, the EchoTip®
Insight procedure and calculations will be carried out as described in the IFU
(Instructions for use).
b. Briefly described, the EchoTip® Insight Needle will be introduced into the
accessory channel of the endoscope and will be placed across the stomach or
duodenal wall and through the liver parenchyma into the portal and hepatic vein
under EUS guidance.
c. Three separate pressure readings will be obtained by the EchoTip® Insight
while the EchoTip® is located in each of the target vessels, flushing the
catheter between each reading (up to 0.5 ml). For the hepatic vein pressure
measurements, it is recommended to obtain these pressure measurements using
both techniques in the same hepatic vein concomitantly.
d. The EchoTip® needle will then be retracted to the sheath and removed. The
study procedure has ended.
TIPS patients
1. Mild sedation: To control for possible variations in portal pressure due to
the influence of anesthetic agents, a first set of HVPG measurements will be
undertaken under mild sedation in accordance with standard of care. During the
HVPG procedure, HVPG will be calculated, using standard balloon occlusion
measurement techniques, as is the standard of care for this procedure (FHVP and
WHVP each in triplicate).
2. General anesthesia: After this first set of measurements, the patient will
receive propofol general anesthesia, which will be maintained by an
anesthesiologist throughout the procedure. The patient will be intubated and
mechanically ventilated.
3. Concomitantly, the EchoTip® InsightTM and HVPG measurements will begin as
outlined above. If possible, the hepatic vein pressure measurements using both
the conventional HVPG and EchoTip® InsightTM should be obtained within the same
hepatic vein. The WHVP and FHVP using the HVPG technique and the direct hepatic
vein pressure measurement using the EchoTip® InsightTM will be obtained in
triplicate. Physicians performing measurements are strongly encouraged not to
share any results.
4. Free portal vein pressure will be measured using the IR technique during the
TIPS procedure before performing an angioplasty and dilating the hepatic tract.
5. The TIPS procedure can proceed as standard of care after completion of the
EchoTip® InsightTM pressure measurements.
Study burden and risks
This is extensively described in the protocol, paragraph 6.0 (Risk Analysis and
Risk Assessment), page 17-20.
Geddes Way 1 NA
West Lafayette, IN 47906
US
Geddes Way 1 NA
West Lafayette, IN 47906
US
Listed location countries
Age
Inclusion criteria
Patients with cirrhosis who have been referred for a procedure where HVPG is
obtained.
Exclusion criteria
General criteria:
1. Patient is < 18 or > 85 years of age
2. Patient is pregnant, breast-feeding, or planning to become pregnant during
the
course of the study
3. Patient is unwilling or unable to sign and date the informed consent
4. Patient is unwilling to comply with the follow-up study schedule
5. Patient for whom endoscopic procedures are contraindicated
6. Patients for whom propofol general anesthesia is contraindicated
Medical criteria:
7. Platelet count <50,000 per mm3
8. International normalized ratio (INR) > 1.7
9. Estimated glomerular filtration rate (eGFR) (see Definitions section) < 50
mL/min/1.73m2
10. Previous transjugular intrahepatic or surgical portosystemic shunt
11. Previous total or partial splenectomy
12. Non-cirrhotic portal hypertension
13. Known history of spontaneous bacterial peritonitis (SBP) within the last
three months irrespective of treatment for SBP
14. Patients with known infection which is not controlled by medical
intervention
15. Portopulmonary hypertension
16. Cardiac decompensation
17. Pre-sinusoidal liver disease
18. Cholestatic liver disease
19. Patient who received endoscopic treatment for upper gastrointestinal (GI)
variceal bleeding within the past 7 days
20. Patients with current hepatocellular carcinoma (HCC)
Anatomical (identified at screening and/or during the endoscopic procedure)
criteria:
21. Portal vein thrombosis
22. Anatomic abnormalities of the hepatic vasculature that prevent access to
the intrahepatic
portion of the portal vein or hepatic veins
23. Evidence of active GI bleeding
24. If the volume of ascites in the path of the needle prevents apposition of
the gastrointestinal
tract and liver
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04987034 |
| CCMO | NL80037.078.22 |