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临床试验/NCT04121520
NCT04121520已完成不适用

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

Hepatopancreatobiliary Surgery Institute of Gansu Province10 个研究点 分布在 7 个国家目标入组 200 人开始时间: 2019年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
10
主要终点
Post-operative satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Post-operative satisfaction

时间窗: 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'.

次要结局

  • Number of post-operative complications(1 day)
  • Methods selection of HVPG measurement(1 day)
  • The result of HVPG measurement(1 day)
  • Pre-operative perception(1 day)
  • Number of intra-operative complications(1 day)

研究者

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolong Qi

Director, Institute of Portal Hypertension

Hepatopancreatobiliary Surgery Institute of Gansu Province

研究点 (10)

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