"Prognostic Role of Portal Hypertension Assessed by Non-invasive Methods to Stratify Surgical Risk in Compensated Advanced Chronic Liver Disease Patients Undergoing Elective Extrahepatic Surgery: ELASTOSURGERY STUDY."
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 37
- 主要终点
- Early post-surgical (at +90 days) complications after extrahepatic surgery
研究概览
简要总结
The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.
详细描述
In the last years, the life expectancy of ACLD patients has increased due to the improvement of the therapeutic strategies of the complications of cirrhosis. .Although surgical procedures have become less invasive the mortality rate in ACLD patients undergoing extrahepatic surgery remains high. For these reasons, an accurate prediction of operative risk for patient-tailored surgical planning becomes crucial.
Purpose of the study: To evaluate the prognostic role of portal hypertension by non- invasive methods in predicting post-operative complications in ACLD patients undergoing elective extrahepatic surgery.
Study type: An international multicenter, prospective, uncontrolled observational study
Study design: In cirrhotic patients undergoing extrahepatic surgery, within one month, a complete baseline evaluation is provided. Baseline evaluation (T0) includes: signature of informed consent, clinical history of liver disease, comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; liver and spleen elastography (with Transient Elastography, ARFI or 2D-SWE).
After surgery, each patient is evaluated at T1 (+90 days) with Elastography, laboratory tests, clinical examination and T2 (+ 365 days) by a clinical examination.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 yrs;
- •Advanced chronic liver disease (LSM>10 kPa)
- •Any etiology (viral, metabolic, alcoholic, cholestatic and autoimmune);
- •Elective extrahepatic surgery planned within three months and requiring regional or general anaesthesia;
- •Patients are willing and able to give informed consent
排除标准
- •Presence of hepatic decompensation at the time of informed consent or previous events of hepatic decompensation during the last three months before enrollment.
- •Presence of portal vein thrombosis
- •Previous placement of TIPS,
- •Prior liver transplantation,
- •Surgical resection or shunt.
- •Presence of active HCC that needed treatment at the time of informed consent
结局指标
主要结局
Early post-surgical (at +90 days) complications after extrahepatic surgery
时间窗: 90 days after surgery
Complications related to the surgical procedure and/or liver disease after the extrahepatic elective surgery
次要结局
- The liver-related events and overall survival at +90 days and + 360 days after extrahepatic surgery(360 days after surgery)
研究者
Antonio Colecchia
Chair Gastroenterology Unit A, Borgo Trento
Azienda Ospedaliera Universitaria Integrata Verona