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Utility of EUS-elastography to Predict Portal Hypertension

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ClinicalTrials.gov Identifier: NCT03155282
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Ecuatoriano de Enfermedades Digestivas

Brief Summary:
Patients with cirrhosis have structural and functional alterations of the liver. The progressive deposition of hepatic fibrosis is related to the subsequent development of portal hypertension (PH), and PH is associated with mayor complications including ascites, hepatic encephalopathy and development of gastroesophageal varices with a high risk of bleeding. Variceal bleeding is a medical emergency associated with a 6-week mortality rate of approximately 10-20%. Liver biopsy is the gold standard for the assessment of hepatic fibrosis, whereas the measurement of hepatic vein pressure gradient (HVPG) is the standard to evaluate PH and upper endoscopy (UE) is the method of choice to detect the presence and grade of gastroesophageal varices. The last two also estimates the risk of variceal bleeding. Unfortunately, clinical investigation of PH implies HVPG measurement or endoscopy for esophageal varices (EV) screening and grading. The first one is an invasive technique, mainly restricted to tertiary centers, that requires personal training, increased health care costs and patient discomfort. The UE, even though has demonstrated utility to predict HVPG (HVPG value ≥ 10 mmHg predicts the presence of EV and a value ≥ 12 mmHg is predictive for variceal bleeding), has been criticized of being subjective. Because of this, alternative test including elastographic techniques, have been develop to assess the severity of PH, the presence of EVs and the risk of variceal bleeding. Elastography is a technique used to measure tissue elasticity and stiffness in real time, by the application of slight compression using a transducer to the targeted tissue. The principle is that tissue compression produces deformation (strain) and that the strain is smaller in harder tissue as compared to softer tissue. Consequently, by measuring the tissue strain induced by compression, it is possible to estimate the tissue hardness. Fibroscan® (FS) (Echosens, París, Francia) uses the principle of one-dimension transient elastography (TE) for the assessment of tissue stiffness. It was used initially for liver stiffness measurement (LSM) and proved to be reliable for the diagnosis of liver cirrhosis and avoid liver biopsy in 90% of cases. Also LSM by TE accurately correlates with the severity of PH and the presence of esophageal varices.

Condition or disease Intervention/treatment
Portal Hypertension Procedure: EUS-E to measure liver and spleen stiffness.

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Diagnostic Accuracy of Spleen and Liver Stiffness Measurement by EUS-elastography, to Predict Portal Hypertension in Patients With Cirrhosis.
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 27, 2017
Actual Study Completion Date : October 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
Cirrhotic group
30 patients with cirrhosis will be evaluated by EUS-E to measure liver and spleen stiffness. Different cirrhosis etiologies will be included like cirrhosis induces by alcohol, virus, autoimmune, nonalcoholic steatohepatitis (NASH), cryptogenic, primary sclerosing cholangitis and primary biliary cirrhosis. The cirrhotic status will be determinate by clinical, biochemical and/or imaging methods (abdominal ultrasound or CT scan).
Procedure: EUS-E to measure liver and spleen stiffness.
The EUS-E quantitative evaluation will be performed on the left hepatic lobe transgastrically. For the SR calculation, the area A will be manually selected including as much of hepatic tissue as possible and the area B will be selected on the red gastric mucosa. For the strain histogram measurement, the ROI selected will have a surface of 60 mm2. The same procedure will be repeated 10 times at different points on the left hepatic lobe and finally the mean SR and SH values will be calculated. The same sequence will be repeated to measure the spleen stiffness. Finally the azygos vein (AV) will be evaluated using EUS Doppler. The mean velocity and the AV diameter will be measure and the AV blood flow volume index (BFVI) will be calculated.

Control group
30 normal patients with no history of liver disease (negative hepatitis B virus and hepatitis C virus serology, insignificant alcohol intake, normal ultrasound and laboratory), in whom a EUS has to be performed to evaluate a esophageal or gastric subepithelial lesion, chronic pancreatitis, will be evaluated by EUS-E to measure liver and spleen stiffness.
Procedure: EUS-E to measure liver and spleen stiffness.
The EUS-E quantitative evaluation will be performed on the left hepatic lobe transgastrically. For the SR calculation, the area A will be manually selected including as much of hepatic tissue as possible and the area B will be selected on the red gastric mucosa. For the strain histogram measurement, the ROI selected will have a surface of 60 mm2. The same procedure will be repeated 10 times at different points on the left hepatic lobe and finally the mean SR and SH values will be calculated. The same sequence will be repeated to measure the spleen stiffness. Finally the azygos vein (AV) will be evaluated using EUS Doppler. The mean velocity and the AV diameter will be measure and the AV blood flow volume index (BFVI) will be calculated.




Primary Outcome Measures :
  1. evaluate the accuracy of LSM and SSM by EUS-elastography (EUS-E) to assess PH in patients with liver cirrhosis and determinate if EUS-E can be used as a surrogate marker for PH. It also aims to find the optimal liver and spleen EUS-E values in predicting [ Time Frame: 4 month ]
    The diagnostic performance of LSM and SSM by EUS elastography will be assessed using sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV), accuracy, likelihood ratio (LR), Odds ratios (OR) with a 95% confidence intervals (CI) and receiver-operating characteristic (ROC) curves.


Secondary Outcome Measures :
  1. correlation between LSM, using transient elastography (Fibroscan) and EUS-E. [ Time Frame: 4 month ]
    Elastography values measured by EUS and Fibroscan will be correlated.

  2. correlation between LSM and SSM by EUS-E and hemodynamic changes in the porto-systemic collateral circulation measure by an increase in azygos vein diameter and blood-flow velocity. [ Time Frame: 4 month ]
    the azygos vein (AV) will be evaluated using EUS Doppler. The mean velocity (Vmean cm/s) and the AV diameter (D) will be measure and the AV blood flow volume index (BFVI) will be calculated [BFVI (cm3 /s) = Vmean (cm/s) X D2 (cm2)]. Finally BFVI will be correlated with LSM and SSM by EUS-E



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with compensated liver cirrhosis will be recruit (cirrhosis induces by alcohol, virus, autoimmune, nonalcoholic steatohepatitis (NASH), cryptogenic, primary sclerosing cholangitis and primary biliary cirrhosis). Patients under β-blocker (BB) therapy will be evaluated independently. This medication acts by lowering portal pressure. Therefore, an effect on spleen stiffness cannot be ruled out. The control group will include normal patients with no history of liver disease, in whom a EUS has to be performed to evaluate a esophageal or gastric subepithelial lesion, chronic pancreatitis.
Criteria

Inclusion Criteria:

  • Patients aged between 18 - 80 years old.
  • Who agree to participate in the study.
  • Compensated liver cirrhotic patients (alcohol, virus, autoimmune, NASH, primary sclerosing cholangitis and primary biliary cirrhosis).

Exclusion Criteria:

  • Moderate or severe perihepatic or perisplenic ascites. The presence of ascites limits the stiffness measurement.
  • Acute and acute on chronic hepatitis. It aims to decrease the influence of inflammation in the elastography evaluation.
  • Multiple focal liver lesions.
  • Cholestatic liver disease and biliary obstruction.
  • Failure to carry out liver TE by Fibroscan. Patients with an interquartile range (IQR) >30% of the median value and a success rate <60% will be excluded from the analysis but included in the intention to treat.
  • Portal vein thrombosis.
  • Esophageal, gastric, liver, spleen or pancreatic tumors that may impede to perform a correct EUS-E
  • Cirrhotic patients with a recent episode of gastrointestinal bleeding or infection that may affect the hemodynamic flow.
  • Splenectomy or history of partial splenic embolization.
  • Pregnancy.
  • Patient' s refusal to participate in this study.

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): NCT03155282


Locations
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Ecuador
Ecuadorian Institute of Digestive Diseases, Omnihospital
Guayaquil, Guayas, Ecuador, 090505
Sponsors and Collaborators
Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
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Principal Investigator: Carlos A Robles-Madranda, MD Ecuadorian Institute of Digestive Diseases
Publications of Results:

Other Publications:
Ophir J, Cespedes EI, Garra BS, et al. Elastography: ultrasound imaging of tissue strain and elastic modulus in vivo. Eur J Ultrasound 1996; 3:49-70.
Bolognesi M, Boscato N. Spleen and liver cirrhosis: relationship between spleen enlargement and portal hypertension in patients with liver cirrhosis. In: Chen TM, ed. New Developments in Liver Cirrhosis Research. Hauppauge, NY: Nova Science Publishers, 2006; 49-67.
Lucidarme D, Foucher J, Le Bail B, Costera L, Villars S, Forzy G, et al. The ratio interquartile range/median value of liver stiffness measurement is a key factor of accuracy of transient elastography (Fibroscans) for the diagnosis of liver fibrosis. Hepatology. 2007; 46: 318
Robles-Medranda C. Gastroint Endosc. 2015; 79 (5): AB440

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Responsible Party: Instituto Ecuatoriano de Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT03155282    
Other Study ID Numbers: MAY 1-2017
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Hypertension
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases