Dataset Information

Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study.

ABSTRACT: INTRODUCTION:Portal hypertension (PH) is a severe disease with a poor outcome. Hepatic venous pressure gradient (HVPG), the current gold standard to detect PH, is available only in few hospitals due to its invasiveness and technical difficulty. This study aimed to establish and assess a novel model to calculate HVPG based on biofluid mechanics. METHODS AND ANALYSIS:This is a prospective, randomised, non-controlled, multicentre trial. A total of 248 patients will be recruited in this study, and each patient will undergo CT, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (124 patients) and validation cohort (124 patients). The researchers will establish and improve the HVPG using biofluid mechanics (HVPGBFM)model in the original cohort and assess the model in the validation cohort. ETHICS AND DISSEMINATION:The study was approved by the Scientific Research Projects Approval Determination of Independent Ethics Committee of Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (approval number 2017-430?T326). Study findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT03470389.

SUBMITTER: Lin JY

PROVIDER: S-EPMC6926408 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPG<sub>BFM</sub>): protocol for a prospective, randomised, non-controlled, multicentre study.

Lin Jia-Yun JY Zhang Chi-Hao CH Zheng Lei L Li Hong-Jie HJ Zhu Yi-Ming YM Fan Xiao X Li Feng F Xia Yan Y Huang Ming-Zhe MZ Yang Sun-Hu SH Qi Xiao-Liang XL Huo Hai-Zhong HZ Chen Hui-Song HS Lou Xiao-Lou XL Luo Meng M

BMJ open 20191203 12

<h4>Introduction</h4>Portal hypertension (PH) is a severe disease with a poor outcome. Hepatic venous pressure gradient (HVPG), the current gold standard to detect PH, is available only in few hospitals due to its invasiveness and technical difficulty. This study aimed to establish and assess a novel model to calculate HVPG based on biofluid mechanics.<h4>Methods and analysis</h4>This is a prospective, randomised, non-controlled, multicentre trial. A total of 248 patients will be recruited in th ...[more]

PMID: 31796472

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Project description:BackgroundEsophagogastric variceal bleeding is a serious complication of decompensated cirrhosis. Transjugular intrahepatic portal shunt (TIPS) is a salvage treatment with clear hemostatic results. However, various complications may occur after TIPS, including postoperative liver failure, and the prognosis is very poor once occurs. Liver failure is a common symptom of severe liver disease with a high mortality rate. This study investigated the incidence of liver failure after TIPS treatment for varicose bleeding.MethodsWe analyzed the data of patients admitted to the First Affiliated Hospital of Soochow University between January 2013 and December 2018 with portal hypertension with an episode of acute gastroesophageal variceal bleeding. A total of 121 patients were referred to the regional liver unit for TIPS. Hepatic venous pressure gradient (HVPG) and clinical data were collected. Patients with incomplete data were excluded, and 93 patients were ultimately enrolled in the study. Primary outcomes were morbidity and hospital mortality within 4 weeks of surgery. The data were retrospectively and consecutively collected and evaluated by univariate and multivariate analyses to identify risk factors of liver failure.ResultsThe patients included 58 males (62.37%) and 35 females (37.63%), and the mean age was 58.43±11.85 years. The main cause was hepatitis B virus (HBV), which was found in 50.54% of patient. The overall surgical success rate was 83.87% (78/93). Of 15 treatment-failure patients, 9 (9.68%) died in hospital. Four patients died of liver failure, accounting for 44.44% of postoperative all-cause deaths. Univariate logistic regression analysis showed that only hepatic venous pressure gradient (HVPG) was an independent risk factor for post-TIPS morbidity [relative risk (RR) 1.156; 95% confidence interval (CI): 1.041 to 1.283; P=0.006]. In addition, HVPG was an independent risk factor for hospital mortality within 4 weeks (RR 1.133; 95% CI: 1.021 to 0.539; P=0.016).ConclusionsPost-TIPS liver failure is a serious complication in patients with cirrhosis. Pre-TIPS HVPG level may be used as a predictor of potential short-term postoperative adverse events.

Project description:Background & aimsEtiologic factor removal (ER) drives recompensation and improves portal hypertension in cirrhosis. Esophageal varices (EV) and portosystemic shunts (PSS) have been found in patients despite hepatic venous pressure gradient (HVPG) dropping below 10 mmHg after ER, questioning HVPG accuracy in reflecting true portal pressure in the setting of ER. We aim to evaluate the correlation of HVPG with direct portal pressure (DPP) in patients with persistence of EV after ER despite HVPG <10 mmHg.MethodsThis is a bicentric 'proof of concept' study evaluating HVPG and ultrasound-guided percutaneous DPP in patients with HCV or alcohol-related cirrhosis with persistent varices and HVPG <10 mmHg after at least 5 years of ER.ResultsSeven patients with HCV and three with alcohol-related cirrhosis with persistent varices and HVPG <10 mmHg after at least 5 years of ER were included. At evaluation, all patients had a patent portal vein and were compensated. The median platelet count was 129.5 (IQR 95-145) × 109/ml, and the median liver stiffness measurement was 16.15 (IQR 14.4-22.3) kPa. In five patients, EV remained the same size (two large and three small), and five downsized to small after ER. Wedge hepatic vein pressure (median 19 [IQR 16.5-20] mmHg) and portal pressure (median 18 [IQR 15-19.5] mmHg) had an excellent correlation (R = 0.93, p <0.0001). Portal pressure gradient (PPG) confirmed the absence of clinically significant portal hypertension as identified by HVPG across all the patients.ConclusionsHVPG accurately reflects PPG in the context of HCV and alcohol-related cirrhosis regression. After ER, EV may persist despite HVPG <10 mmHg. The benefit of prophylaxis in patients with EV and HVPG <10 mmHg is unknown. Future studies with clinical endpoints are needed to validate our findings.Impact and implicationsDespite a favorable evolution after the removal of the etiologic factor, varices persist in some patients, and there is a lack of concise guidelines for the evaluation and management of portal hypertension in this population. Our research underscores the persistence of varices in the absence of clinically significant portal hypertension and significantly demonstrates the accuracy of hepatic venous pressure gradient (HVPG) in reflecting portal vein pressure in this specific patient group. These findings emphasize the crucial role of HVPG in the assessment of portal hypertension after etiologic factor removal and lay the groundwork for further investigation into clinical outcomes and the necessity of non-selective beta-blockers in individuals with persistent varices after the removal of etiologic factor.

Project description:Background and aimsSustained virologic response (SVR) to interferon (IFN)-free therapies ameliorates portal hypertension (PH); however, it remains unclear whether a decrease in hepatic venous pressure gradient (HVPG) after cure of hepatitis C translates into a clinical benefit. We assessed the impact of pretreatment HVPG, changes in HVPG, and posttreatment HVPG on the development of hepatic decompensation in patients with PH who achieved SVR to IFN-free therapy. Moreover, we evaluated transient elastography (TE) and von Willebrand factor to platelet count ratio (VITRO) as noninvasive methods for monitoring the evolution of PH.Approach and resultsThe study comprised 90 patients with HVPG ≥ 6 mm Hg who underwent paired HVPG, TE, and VITRO assessments before (baseline [BL]) and after (follow-up [FU]) IFN-free therapy. FU HVPG but not BL HVPG predicted hepatic decompensation (per mm Hg, hazard ratio, 1.18; 95% confidence interval, 1.08-1.28; P < 0.001). Patients with BL HVPG ≤ 9 mm Hg or patients who resolved clinically significant PH (CSPH) were protected from hepatic decompensation. In patients with CSPH, an HVPG decrease ≥ 10% was similarly protective (36 months, 2.5% vs. 40.5%; P < 0.001) but was observed in a substantially higher proportion of patients (60% vs. 24%; P < 0.001). Importantly, the performance of noninvasive methods such as TE/VITRO for diagnosing an HVPG reduction ≥ 10% was inadequate for clinical use (area under the receiver operating characteristic curve [AUROC], < 0.8), emphasizing the need for HVPG measurements. However, TE/VITRO were able to rule in or rule out FU CSPH (AUROC, 0.86-0.92) in most patients, especially if assessed in a sequential manner.ConclusionsReassessment of HVPG after SVR improved prognostication in patients with pretreatment CSPH. An "immediate" HVPG decrease ≥ 10% was observed in the majority of these patients and was associated with a clinical benefit, as it prevented hepatic decompensation. These results support the use of HVPG as a surrogate endpoint for interventions that lower portal pressure by decreasing intrahepatic resistance.

Dataset Information

Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study.

Publications

Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPG<sub>BFM</sub>): protocol for a prospective, randomised, non-controlled, multicentre study.

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