Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey

Study Overview
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Brief Summary
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Hepatic venous pressure gradient (HVPG) is an invasive test and requires technical skills of the operator and specialized instruments. HVPG measurement and anesthesia can cause stress responses in the body, which in turn lead to inflammatory response and immune function suppression. Thus, the perioperative care for patients undergoing HVPG measurement is crucial. This research trial studies comprehensive patient and medical worker questionnaires in predicting complications in patients with cirrhosis undergoing HVPG measurement. Comprehensive patient and medical worker questionnaires may help identify complications, such as the need for assistance in taking medication, decreased mobility and released tension that may improve outcomes.

Detailed Description
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Portal hypertension is an important factor affecting the clinical outcomes of cirrhosis patients, and its severity determines the occurrence of development of cirrhosis complications, such as rupture and bleeding of gastroesophageal varices, ascites, and hepatorenal syndrome. The direct measurement of portal pressure is an extremely invasive and high-risk procedure. In addition, changes in intra-abdominal pressure will affect the portal pressure, which leads to unreliable results. The hepatic venous pressure gradient (HVPG) is the difference between wedged hepatic venous pressure and free hepatic venous pressure and reflects the pressure difference between the hepatic portal vein and the intra-abdominal veins. In recent years, the status of HVPG in clinical application of cirrhotic portal hypertension has gradually improved. In 2016, the American Association for the Study of Liver Diseases (AASLD) issued a consensus on risk stratification, diagnosis, and management of portal hypertensive bleeding in cirrhosis and re-emphasized the value of HVPG in assessing the cirrhosis staging, occurrence of complications and treatment goals. However, HVPG is an invasive test and requires technical skills of the operator and specialized instruments. HVPG measurement and anesthesia can cause stress responses in the body, which in turn lead to inflammatory response and immune function suppression. Thus, the perioperative care for patients undergoing HVPG measurement is crucial. This research trial studies comprehensive patient and medical worker questionnaires in predicting complications in patients with cirrhosis undergoing HVPG measurement. Comprehensive patient and medical worker questionnaires may help identify complications, such as the need for assistance in taking medication, decreased mobility and released tension that may improve outcomes.

Official Title
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Perioperative Care of Hepatic Venous Pressure Gradient (HVPG) Measurement (CHESS1904): An International Multicenter Survey

Conditions
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Portal Hypertension, Cirrhosis, Liver

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants must meet the following criteria: aged between 18-75 years, no restriction on gender; clinically and/or pathologically diagnosed sinusoidal cirrhosis; with written informed consent scheduled to undergo HVPG measurement according to the following indications: 1) assessment of the efficacy of primary and secondary prophylactic drugs for gastroesophageal variceal bleeding; 2) predicting the risk of gastroesophageal variceal bleeding and guiding the selection of the treatment regimens; 3) predicting of risk, progression, and clinical outcomes of decompensation events in cirrhosis; 4) evaluation of the efficacy of new drugs; 5) evaluation of the accuracy of new non-invasive techniques; diagnosis and differential diagnosis of types of portal hypertension. Exclusion Criteria: Those cases that meet any of the following criteria should be excluded: contradictions for HVPG measurement; pregnant or lactating woman; severe coagulopathy (international normalized ratio>5); severe heart, lung, or kidney disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>At time of consent and within the same day of HVPG measurement, participants will be asked to complete a pre-operative assessment. Relevant statistics will be recorded during the HVPG procedure. Post-operative complication will also be collected and the satisfaction survey will be conducted. | Other: Questionnaire<br>* Comprehensive perioperative assessment Questionnaire administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative satisfaction | After the procedure of HVPG (within the same day), participants will be asked to complete a pain scale which was experienced during and after the HVPG procedure. The pain scale ranges from 0 to 10 with 0 representing 'not at all' and 10 representing 'excessively'. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative perception | At time of consent and within the same day of HVPG procedure, participants will be asked to complete a pain scale which was felt to be experienced during the HVPG procedure. The pain scale ranges from 0 to 10 with 0 representing 'not at all' and 10 representing 'excessively'. | 1 day | 
| Number of intra-operative complications | Number of complications (e.g. vasovagal reflex, arrhymia, inadvertent arterial puncture, hypersensitivity to contrast agents, pneumothorax) happened during the HVPG procedure. | 1 day | 
| Number of post-operative complications | Number of complications (e.g. bleeding at the puncture point, contrast-induced nephropathy, infection, jugular vein thrombosis) happened after the HVPG procedure. | 1 day | 
| Methods selection of HVPG measurement | Including the selection of routes for insertion of catheter, hepatic vein used for the assessment and the angiographic catheter used during the HVPG procedure. | 1 day | 
| The result of HVPG measurement | The mean value of HVPG measurements. | 1 day |