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

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

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.

Study Overview

• Status: Completed
• Conditions: Portal Hypertension; Cirrhosis, Liver
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

• Study Contact: Name: Xiaolong Qi, M.D.; Phone Number: +86-18588602600; Email: qixiaolong@vip.163.com
• Study Contact Backup: Name: Xinwen Yan, M.D.; Phone Number: +86-18565120926; Email: 812895688@qq.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with cirrhosis who were scheduled to undergo HVPG measurement

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; 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; Comprehensive perioperative assessment; Questionnaire administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Collaborators: LanZhou University; Universidade Federal de Pernambuco; Shandong Provincial Hospital; Zhejiang University; Ankara University; Xingtai People's Hospital; Chiba University Graduate School of Medicine; Universitas Indonesia, Cipto Mangunkusumo National General Hospital; S. Orsola-Malpighi Hospital, University of Bologna; Hanyang University College of Medicine
• Investigators: Principal Investigator: Xiaolong QI, M.D., LanZhou University; Principal Investigator: Necati Örmeci, M.D., Ankara University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: October 6, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: CHESS1904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No