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

NCT04121520 | Completed DMC

• 1 other identifier: CHESS1904
• Study Type: observational
• Target: 200
• Locations: 7 countries
• Sites: 10

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.

Conditions

Portal Hypertension; Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pre-operative perception

  1 day

• Number of intra-operative complications

  1 day

• Number of post-operative complications

  1 day

• Methods selection of HVPG measurement

  1 day

• The result of HVPG measurement

  1 day

Study Arms (1)

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

Interventions

Questionnaire OTHER

1. Comprehensive perioperative assessment 2. Questionnaire administration

Observational

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with cirrhosis who were scheduled to undergo HVPG measurement

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (10)

Universidade Federal de Pernambuco

Recife, Brazil

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Xingtai People's Hospital

Xingtai, Hebei, China

Location

Shandong Provincial Hospital affiliated to Shandong University

Jinan, Shandong, China

Location

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Universitas Indonesia, Cipto Mangunkusumo National General Hospital

Jakarta, Indonesia

Location

S. Orsola-Malpighi Hospital, University of Bologna

Bologna, Italy

Location

Chiba University Graduate School of Medicine

Chiba, Japan

Location

Hanyang University College of Medicine

Seoul, South Korea

Location

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26047908 BACKGROUND

• 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.

  PMID: 27786365 BACKGROUND

• 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.

  PMID: 19724251 BACKGROUND

• 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.

  PMID: 30215362 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal; Liver Cirrhosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xiaolong Qi, M.D.

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Necati Örmeci, M.D.

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute of Portal Hypertension

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 10, 2019
• Study Start: October 16, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

TU (1); ID (1); CN (4); JP (1); BR (1); IT (1); KR (1)