liver cirrhosis, portal hypertension increased venous liver pressure scarring of the liver
Conditions
Interventions
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 anesth
Sponsors
Cook Research Incorporated
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.
Exclusion criteria
Exclusion criteria: General criteria: 1. Patient is 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 1.7 9. Estimated glomerular filtration rate (eGFR) (see Definitions section)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Netherlands
Outcome results
None listed