Validation of Baveno VII Criteria and Spleen Stiffness Measurement on Outcome Prediction in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Composite of incident high-risk varices, hepatic decompensation and liver-related mortality
研究概览
简要总结
This is a single-centre, prospective cohort study. Consecutive patients with compensated liver disease and hepatocellular carcinoma (HCC) for curative-intent treatment will be invited to this study. The study follow-up duration will be five years. The primary outcome is the composite of incident high-risk varices, hepatic decompensation and liver-related mortality. The participants will undergo transient elastography at baseline and then half-yearly post-HCC curative treatment; and oesophagogastroduodenoscopy (OGD) at baseline and then at year 1, 3 and 5 post-HCC curative treatment. Clinical assessments and laboratory tests will also be done at baseline and every 6 months until year 5 to identify any clinical events.
详细描述
1.1 Significance of chronic liver disease and hepatocellular carcinoma
Hepatocellular carcinoma (HCC) burdens the global healthcare system with a drastic increase in incidence by 70% from 1990 to approximately 747,000 cases and 480,000 deaths in 2019.
Despite implementation of screening ultrasound in at-risk populations and advances in the treatment of HCC in recent decades, HCC remains a lethal malignancy with a median survival of less than a year. Apart from the oncological factors, the underlying liver disease has an important impact on morbidity and mortality in patients with HCC as most HCC develop under the setting of chronic hepatic inflammation and fibrosis from patients with advanced chronic liver diseases of various aetiologies.
1.2 Non-invasive measurement of portal hypertension
In the Baveno VI consensus, the term "compensated advanced chronic liver disease" (cACLD) described spectrum of chronic liver diseases ranging from advanced liver fibrosis to compensated cirrhosis. Patients with cACLD are at risk of hepatic decompensation and development of HCC, especially for those with clinically significant portal hypertension (CSPH), which is conventionally measured invasively by hepatic venous pressure gradient (HVPG). The recently updated Baveno VII consensus implemented a non-invasive approach by incorporating liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) and platelet count in ruling in or out CSPH in patients with cACLD. In the Baveno VII consensus and as well incorporated into the latest practice guidance on portal hypertension, LSM ≤ 15kPa and platelet count ≥ 150 x 109/L rules out CSPH, whereas LSM > 25kPa, LSM 20-25kPa with platelet count <150 x 109/L or LSM 15-20kPa with platelet count <110 x 109/L rule in CSPH, prompting the presence of gastroesophageal varices. As well in Baveno VI consensus, LSM < 20 kPa with platelet count > 150 x 109/L also implies a minimal risk of high-risk varices and thus can have a screening oesophagogastroduodenoscopy (OGD) spared.
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
- •Aged 18 or above
- •Known chronic liver disease(s)
- •HCC for curative-intent treatment (defined by HCC diagnosed with typical radiological features or histology, and planned for surgical resection or local ablative therapy as a curative-intent treatment)
排除标准
- •Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome)
- •o Child's B cirrhosis without decompensating events is not excluded
- •Past history of HCC (ie. The current HCC is a recurrence of priorly treated HCC or a second de novo HCC after previous first HCC)
- •Non-primary liver tumour (such as secondary liver tumour due to metastasis from another distant primary tumour)
- •History of liver transplantation or plan for liver transplantation as the modality of curative-intent HCC treatment
- •Asplenism or history of splenectomy
- •Contraindication to OGD (eg. Intestinal perforation of obstruction)
- •Serious medical illness with limited life expectancy of less than 6 months
- •Pregnancy
- •Unable to obtain or refusal of informed consent from patient
结局指标
主要结局
Composite of incident high-risk varices, hepatic decompensation and liver-related mortality
时间窗: 5 years
Composite of incident high-risk varices, hepatic decompensation and liver-related mortality
次要结局
- Development of each hepatic decompensation event(5 years)
- Recurrence of hepatocellular carcinoma(5 years)
- Changes in Child-Pugh and Model for End-stage Liver Disease scores(5 years)
- Change in liver and spleen stiffness measurements(5 years)
研究者
Jimmy Che-To Lai
Assistant Professor (Clinical)
Chinese University of Hong Kong