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临床试验/NCT05044663
NCT05044663已完成不适用

Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease - A Cross-Sectional Study.

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2021年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
325
试验地点
1
主要终点
Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD.

研究概览

简要总结

Patients with chronic liver disease (CLD) are at risk of developing clinically significant portal hypertension (CSPH). In the Baveno VI consensus a new term "compensated advanced chronic liver disease (cACLD)'' has been proposed to better reflect that the spectrum of severe fibrosis and cirrhosis is a continuum in asymptomatic patients. Liver stiffness by TE is sufficient to suspect cACLD in asymptomatic subjects with known causes of CLD. TE values <10 kPa in the absence of other known clinical signs rule out cACLD; values between 10 and 15 kPa are suggestive of cACLD but need further test for confirmation; values >15 kPa are highly suggestive of cACLD. Patients with a liver stiffness <20 kPa and with a platelet count >150,000 have a < 5 % risk of having varices requiring treatment, and can avoid screening endoscopy. SSM can also predict the presence of CSPH and varices requiring treatment. Because of restrictive nature of Baveno VI, recent Baveno VII guidelines state that patients not satisfying Baveno VI criterai acan have endoscopy avoided if their spleen stiffness is less than 40kPa. Some studies have shown superiority of splenic stiffness over liver stiffness in predicting varices requiring treatment likely attributable to the better performance of SSM compared with LSM in more severe portal hypertension because it reflects better the hemodynamic component of portal hypertension. However, there are few studies on MASLD and most are on viral hepatitis related cACLD. Moreover, very few studies are published on splenic stiffness from Indian subcontinent. Hence, we intend to do the study assessing diagnostic utility of splenic and liver stiffness and validate the Baveno VII algorothm in predicting varices needing treatment in MASLD related cACLD and compare from other noninvasive markers.

详细描述

Aim - to study the diagnostic accuracy of liver stiffness and splenic stiffness in predicting esophageal varices needing treatment in patients of NASH related cACLD.

Primary objective:

To assess the utility of liver stiffness and splenic stiffness in making a composite score to predict presence of esophageal varices needing treatment in patients of NASH related cACLD.

Secondary objectives:

  1. To study the correlation of liver stiffness and splenic stiffness with grade of esophageal varices.
  2. To study utility of other noninvasive scores, such as Baveno VI criteria, expanded Baveno VI criteria, LSPS (LS x spleen diameter / platelet ratio score), platelet count to spleen diameter ratio (PSR), AST/ALT ratio, APRI, FIB-4, in predicting presence of esophageal varices needing treatment in patients of NASH related cACLD.
  3. To study utility of noninvasive tests in predicting presence of esophageal varices needing treatment in patients of HBV or HCV related cACLD.
  4. To study correlation of liver and splenic stiffness with HVPG and MELD score in patients of NASH related cACLD.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • MASLD will be diagnosed by liver biopsy or ultrasound steatosis / Fibroscan CAP > 250 dB + any 1 criteria of metabolic syndrome:
  • Waist circumference 90 ≥ cm for males or ≥80 cm for females
  • Triglycerides ≥150 mg/dL
  • HDL-C < 40 mg/dL in males or < 50 mg/dl in females
  • systolic blood pressure (SBP) ≥130 mm Hg or diastolic blood pressure (DBP) ≥ 85 mmHg or both and
  • Fasting plasma glucose ≥ 100 mg/dL. cACLD is defined with Liver stiffness ≥10 kPa. Ultrasound examination, blood examination and upper gastrointestinal endoscopy will be performed within 1 month of Fibroscan examination. HVPG if indicated will be done within 1 month of Fibroscan.

排除标准

  • Age < 18 and > 70 years, Other etiologies of liver disease.
  • Past or present history of decompensation (ascites, variceal bleed, hepatic encephalopathy, jaundice),
  • Child Pugh B or C,
  • unreliable liver and splenic stiffness in Fibroscan examination,
  • Transjugular intrahepatic portosystemic shunt, significant alcohol intake (> 30 gm/day (M) and 20gm/day (F),
  • Acute on chronic liver failure,
  • AST and/or ALT > 5 times the upper limit of normal.
  • Hepatocellular carcinoma or any space-occupying lesion in the liver,
  • Portal vein thrombosis,
  • Biliary obstruction,
  • Cardiac failure,
  • Prior variceal endotherapy or ongoing beta blocker treatment.
  • Any malignancy,
  • ICD / pacemaker,
  • No consent.

结局指标

主要结局

Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD.

时间窗: Day 0

次要结局

  • Utility of other NITs in predicting VNT in MASLD related cACLD(Day 0)
  • Correlation of LSM and SSM with grade of EV(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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