SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

Официальное название

Spleen Stiffness Measurement Predicts Short-term Outcomes of Chronic Liver Disease Inpatients With Acute Liver Injury: a Prospective, Observational and Multicentre Study

Обзор

In this study, a single non-invasive tool, spleen stiffness measurement (SSM), was used to monitor the disease regression of inpatients with chronic liver disease (CLD) and acute liver injury. The present study aimed to establish an early diagnosis warning model for acute-on-chronic liver failure (ACLF) by SSM and investigate the effect of dynamic changes in SSM on the short-term prognosis (28-day, 90-day morbidity and mortality) of inpatients with CLD and acute liver injury.

Подробное описание

Portal hypertension is a major complication of cirrhosis and can lead to serious clinical manifestations such as ascites, hepatic encephalopathy, variceal bleeding, etc. Colecchia et al. proposed the use of spleen stiffness measurement (SSM) to dynamically monitor portal pressure and to predict the risk of oesophageal varices. Studies have now demonstrated the utility of SSM in assessing portal hypertension, ruling out high-risk varices, and predicting clinical complications in cirrhotic patients. Furthermore, the Baveno VII consensus of portal hypertension has included SSM in its recommendations for non-invasive screening. Pathogenic triggers, important clinical events (ascites, encephalopathy, etc.), and short-term prognosis in compensated advanced chronic liver disease are associated with portal pressure. Exploring the relationship between portal hypertension and liver failure development would be of great clinical and scientific value. The present study is mainly based on a single non-invasive tool, SSM, to monitor the disease regression of chronic liver disease (CLD) inpatients with acute liver injury, to establish an early warning model for early diagnosis of acute-on-chronic liver failure, and to investigate the effect of dynamic changes in SSM on the short-term prognosis of inpatients with CLD and acute liver injury.

Вмешательства

• Устройство FibroScan® Expert 630
  The SSM by FibroScan 630 was first performed after admission, repeated at the day 5±2 as soon as feasible, and finally evaluated before discharge.

Первичные конечные точки

• 90-day transplant-free mortality [Срок оценки: Day 90]

Вторичные конечные точки (3)

• Incidence of acute kidney injury (AKI) [Срок оценки: From admission to Day 90]
• Rate of progression to acute-on-chronic liver failure (ACLF) [Срок оценки: From admission to Day 90]
• Rate for readmission of patients hospitalized with acute liver injury [Срок оценки: From discharge to Day 90]

Критерии участия

Критерии включения

• Age between 18 years and 80 years
• Chronic liver diseases regardless of etiology
• Acute liver injury with total bilirubin ≥ 3 mg/dl regardless of inducement

Критерии исключения

• Prior surgery of liver diseases before enrollment such as liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy and partial splenic embolization
• Severe extrahepatic diseases such as chronic obstructive pulmonary disease level IV, chronic kidney disease with end-stage renal failure, myocardial infarction within 3 months before admission
• Receiving Immunosuppressive drugs for reasons rather than chronic liver diseases
• Diagnosis of hepatocellular carcinoma or other non-liver malignancies during screening period
• Serious mental illnesses such as anxiety, depressive disorders to obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD)
• The pregnant
• Jaundice due to biliary obstruction or cholestasis
• Unsuitable to participate in this study judging by investigators

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical Uni — Гуанчжоу

Публикации

• de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available. PMID 26047908
• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30. PMID 35120736
• Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013 Jun;144 PMID 23474284
• Wu T, Li J, Shao L, Xin J, Jiang L, Zhou Q, Shi D, Jiang J, Sun S, Jin L, Ye P, Yang L, Lu Y, Li T, Huang J, Xu X, Chen J, Hao S, Chen Y, Xin S, Gao Z, Duan Z, Han T, Wang Y, Gan J, Feng T, Pan C, Chen Y, Li H, Huang Y, Xie Q, Lin S, Li L, Li J; Chinese Group on the Study of Severe Hepatitis B (COSSH).. Development of diagnostic criteria and a prognostic score for hepatitis B virus-related acute-o PMID 28928275
• Li J, Liang X, You S, Feng T, Zhou X, Zhu B, Luo J, Xin J, Jiang J, Shi D, Lu Y, Ren K, Wu T, Yang L, Li J, Li T, Cai Q, Sun S, Guo B, Zhou X, Chen J, He L, Li P, Yang H, Hu W, An Z, Jin X, Tian J, Wang B, Chen X, Xin S, Li J; Chinese Group on the Study of Severe Hepatitis B (COSSH). Development and validation of a new prognostic score for hepatitis B virus-related acute-on-chronic liver failure. PMID 34090929
• de Franchis R, Pascal JP, Ancona E, Burroughs AK, Henderson M, Fleig W, Groszmann R, Bosch J, Sauerbruch T, Soederlund C, et al. Definitions, methodology and therapeutic strategies in portal hypertension. A Consensus Development Workshop, Baveno, Lake Maggiore, Italy, April 5 and 6, 1990. J Hepatol. 1992 May;15(1-2):256-61. doi: 10.1016/0168-8278(92)90044-p. No abstract available. PMID 1506645
• Karagiannakis DS, Voulgaris T, Siakavellas SI, Papatheodoridis GV, Vlachogiannakos J. Evaluation of portal hypertension in the cirrhotic patient: hepatic vein pressure gradient and beyond. Scand J Gastroenterol. 2018 Oct-Nov;53(10-11):1153-1164. doi: 10.1080/00365521.2018.1506046. Epub 2018 Oct 21. PMID 30345856
• Berzigotti A, Bosch J, Boyer TD. Use of noninvasive markers of portal hypertension and timing of screening endoscopy for gastroesophageal varices in patients with chronic liver disease. Hepatology. 2014 Feb;59(2):729-31. doi: 10.1002/hep.26652. Epub 2013 Dec 24. No abstract available. PMID 23913844

Идентификаторы

NCT: NCT06173947 · NFEC-2023-495

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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