Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Gradient Measurement Compared to the Transjugular Approach: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS
研究概览
简要总结
This study will directly compare the endoscopic ultrasound guided approach to obtain adequate liver biopsies and portal pressure gradient measurements to the current standard of care which uses the transjugular approach.
详细描述
Current guidelines recommend that when a hepatic venous pressure gradient and a liver biopsy are needed, the liver biopsy should be done by the transjugular approach during the same session. A major limitation is that liver biopsies obtained by the transjugular approach meet quality criteria proposed by the American Association for the Study of Liver Diseases (at least 2-3cm with at least 11 complete portal tracts) in only 40% of cases.
Recent studies have shown that endoscopic ultrasound-guided liver biopsy (EUS-LB) can achieve a high rate of adequate liver biopsies using the same strict criteria described above. In addition, a novel endoscopic-ultrasound adapted manometer allows the safe and accurate measurement of portal pressure gradient (PPG) which correlates well with hepatic venous pressures (HVPG) obtained by the transjugular approach. Unfortunately to this day, no randomized controlled trials has compared the EUS-LB and PPG vs TJ-LB and HVPG directly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
As EUS and TJ procedures are inherently different, patients and health-care workers directly involved in the procedure, including nurses, physicians, and technicians, will not be blinded. Pathologists interpreting liver biopsies will be blinded to the intervention group.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 18 years
- •Undergoing evaluation for chronic liver disease or portal hypertension
- •Planned to undergo a liver biopsy and HVPG by their treating hepatologist for clinical purposes
- •Signed informed consent
排除标准
- •Uncorrectable coagulopathy (INR above 1.5)
- •Uncorrectable thrombocytopenia (Platelets under 50,000)
- •Anticoagulation or antiplatelet therapy that cannot be discontinued
- •Surgically altered upper digestive anatomy
- •Biliary obstruction
- •Grade II ascites or more
- •Intrahepatic portal vein thrombosis
- •Previous liver transplantation
- •Past hypersensitivity reaction to midazolam or ketamine
- •History of psychotic disorder
- •Pregnancy
研究组 & 干预措施
Transjugular approach
Transjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB).
干预措施: Transjugular hepatic venous pressure gradient measurement with liver biopsy (Procedure)
Endoscopic ultrasound approach
Endoscopic ultrasound portal pressure gradient measurement with liver biopsy (EUS-PPG-LB)
干预措施: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy (Procedure)
结局指标
主要结局
Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS
时间窗: 2 weeks
Liver Biopsy (LB) specimens are defined as a biopsy of at least 25mm in length following formalin fixation and at least 11 complete portal tracts. The Portal pressure gradient (PPG) measurement is defined as two PPG values with less than 2mmHg difference.
次要结局
- Adverse events(30 days)
- PPG-related outcomes(1 day)
- Liver biopsy-related outcomes(2 weeks)
- Technical success(1 day)
- Satisfaction with sedation(1 day)
研究者
Amine Benmassaoud
Principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre