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

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ClinicalTrials.gov Identifier: NCT04121520
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
LanZhou University
Shandong Provincial Hospital
Xingtai People's Hospital
Zhejiang University
Ankara University
Chiba University Graduate School of Medicine
Universitas Indonesia, Cipto Mangunkusumo National General Hospital
S. Orsola-Malpighi Hospital, University of Bologna
Universidade Federal de Pernambuco
Hanyang University College of Medicine
Information provided by (Responsible Party):
Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

Study Description
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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.

Condition or disease Intervention/treatment
Portal Hypertension Cirrhosis, Liver 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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Care of Hepatic Venous Pressure Gradient (HVPG) Measurement (CHESS1904): An International Multicenter Survey
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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
  1. Comprehensive perioperative assessment
  2. Questionnaire administration


Outcome Measures
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Primary Outcome Measures :
  1. Post-operative satisfaction [ Time Frame: 1 day ]
    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'.


Secondary Outcome Measures :
  1. Pre-operative perception [ Time Frame: 1 day ]
    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'.

  2. Number of intra-operative complications [ Time Frame: 1 day ]
    Number of complications (e.g. vasovagal reflex, arrhymia, inadvertent arterial puncture, hypersensitivity to contrast agents, pneumothorax) happened during the HVPG procedure.

  3. Number of post-operative complications [ Time Frame: 1 day ]
    Number of complications (e.g. bleeding at the puncture point, contrast-induced nephropathy, infection, jugular vein thrombosis) happened after the HVPG procedure.

  4. Methods selection of HVPG measurement [ Time Frame: 1 day ]
    Including the selection of routes for insertion of catheter, hepatic vein used for the assessment and the angiographic catheter used during the HVPG procedure.

  5. The result of HVPG measurement [ Time Frame: 1 day ]
    The mean value of HVPG measurements.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with cirrhosis who were scheduled to undergo HVPG measurement
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121520


Contacts
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Contact: Xiaolong Qi, M.D. +86-18588602600 qixiaolong@vip.163.com
Contact: Xinwen Yan, M.D. +86-18565120926 812895688@qq.com

Locations
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Brazil
Universidade Federal de Pernambuco Recruiting
Recife, Brazil
Contact: Rafael Ximenes, M.D.         
Principal Investigator: Rafael Ximenes         
China, Gansu
The First Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China
Contact: Huaping Wei, M.D.         
Contact: Lei Li, M.D.         
Principal Investigator: Huaping Wei         
Sub-Investigator: Lei Li         
China, Hebei
Xingtai People's Hospital Recruiting
Xingtai, Hebei, China
Contact: Changzeng Zuo, M.D.         
Contact: Bo Zhang, M.D.         
Principal Investigator: Changzeng Zuo         
Sub-Investigator: Bo Zhang         
China, Shandong
Shandong Provincial Hospital affiliated to Shandong University Recruiting
Jinan, Shandong, China
Contact: Chunqing Zhang, M.D.         
Contact: Guangchuan Wang, M.D.         
Principal Investigator: Chunqing Zhang         
Sub-Investigator: Guangchuan Wang         
China, Zhejiang
The First Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Junhui Sun, M.D.         
Contact: Tanyang Zhou, M.D.         
Principal Investigator: Junhui Sun         
Indonesia
Universitas Indonesia, Cipto Mangunkusumo National General Hospital Recruiting
Jakarta, Indonesia
Contact: Cosmas Rinaldi A. Lesmana, M.D.         
Principal Investigator: Cosmas Rinaldi A. Lesmana         
Italy
S. Orsola-Malpighi Hospital, University of Bologna Recruiting
Bologna, Italy
Contact: Rita Golfieri, M.D.         
Principal Investigator: Rita Golfieri         
Japan
Chiba University Graduate School of Medicine Recruiting
Chiba, Japan
Contact: Hitoshi Maruyama, M.D.         
Principal Investigator: Hitoshi Maruyama         
Korea, Republic of
Hanyang University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Joo Hyun Sohn, M.D.         
Principal Investigator: Joo Hyun Sohn         
Turkey
Ankara University School of Medicine Recruiting
Ankara, Turkey
Contact: Necati Örmeci, M.D.         
Principal Investigator: Necati Örmeci         
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
LanZhou University
Shandong Provincial Hospital
Xingtai People's Hospital
Zhejiang University
Ankara University
Chiba University Graduate School of Medicine
Universitas Indonesia, Cipto Mangunkusumo National General Hospital
S. Orsola-Malpighi Hospital, University of Bologna
Universidade Federal de Pernambuco
Hanyang University College of Medicine
Investigators
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Principal Investigator: Xiaolong Qi, M.D. LanZhou University
Principal Investigator: Necati Örmeci, M.D. Ankara University
More Information
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Publications:

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Responsible Party: Xiaolong Qi, Director, Institute of Portal Hypertension, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT04121520     History of Changes
Other Study ID Numbers: CHESS1904
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Portal
Liver Cirrhosis
Liver Diseases
Digestive System Diseases