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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121520
• Other study ID #: CHESS1904
• Status: Completed
• Start date: October 16, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Eligible participants must meet the following criteria:

1. aged between 18-75 years, no restriction on gender;

2. clinically and/or pathologically diagnosed sinusoidal cirrhosis;

3. with written informed consent

4. 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:

1. contradictions for HVPG measurement;

2. pregnant or lactating woman;

3. severe coagulopathy (international normalized ratio>5);

4. severe heart, lung, or kidney disease.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Other:
• Questionnaire
Comprehensive perioperative assessment Questionnaire administration

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife
China	The First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Shandong Provincial Hospital affiliated to Shandong University	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Xingtai People's Hospital	Xingtai	Hebei
Indonesia	Universitas Indonesia, Cipto Mangunkusumo National General Hospital	Jakarta
Italy	S. Orsola-Malpighi Hospital, University of Bologna	Bologna
Japan	Chiba University Graduate School of Medicine	Chiba
Korea, Republic of	Hanyang University College of Medicine	Seoul
Turkey	Ankara University School of Medicine	Ankara

Sponsors (11)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province	Ankara University, Chiba University Graduate School of Medicine, Hanyang University College of Medicine, LanZhou University, S. Orsola-Malpighi Hospital, University of Bologna, Shandong Provincial Hospital, Universidade Federal de Pernambuco, Universitas Indonesia, Cipto Mangunkusumo National General Hospital, Xingtai People's Hospital, Zhejiang University

Countries where clinical trial is conducted

Brazil,  China,  Indonesia,  Italy,  Japan,  Korea, Republic of,  Turkey, 

References & Publications (4)

Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1. — View Citation

de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available. — View Citation

Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available. Erratum In: Hepatology. 2017 Jul;66(1):304. — View Citation

Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The result of HVPG measurement	The mean value of HVPG measurements.	1 day