Clinical trial NCT04121520: Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey
Official title: Perioperative Care of Hepatic Venous Pressure Gradient (HVPG) Measurement (CHESS1904): An International Multicenter Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
Cirrhosis, Liver
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Shandong Provincial Hospital
name: Xingtai People's Hospital
name: Zhejiang University
name: Ankara University
name: Chiba University Graduate School of Medicine
name: Universitas Indonesia, Cipto Mangunkusumo National General Hospital
name: S. Orsola-Malpighi Hospital, University of Bologna
name: Universidade Federal de Pernambuco
name: Hanyang University College of Medicine
First posted: 2019-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with cirrhosis who were scheduled to undergo HVPG measurement

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative satisfaction
timeFrame: 1 day
Secondary outcomes:
measure: Pre-operative perception
timeFrame: 1 day
measure: Number of intra-operative complications
timeFrame: 1 day
measure: Number of post-operative complications
timeFrame: 1 day
measure: Methods selection of HVPG measurement
timeFrame: 1 day
measure: The result of HVPG measurement
timeFrame: 1 day
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Jinan
country: China
facility: Shandong Provincial Hospital affiliated to Shandong University
state: Shandong
city: Hangzhou
country: China
facility: The First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Jakarta
country: Indonesia
facility: Universitas Indonesia, Cipto Mangunkusumo National General Hospital
city: Bologna
country: Italy
facility: S. Orsola-Malpighi Hospital, University of Bologna
city: Chiba
country: Japan
facility: Chiba University Graduate School of Medicine
city: Seoul
country: Korea, Republic of
facility: Hanyang University College of Medicine
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: LanZhou University
name: Xiaolong Qi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Necati Örmeci, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.