Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements in Patients with Cirrhosis and Non Cirrhotic Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Correlation of the porto systemic pressure gradient measured by EUS and TIPS
研究概览
简要总结
Portal hypertension (PHT) is the main consequence of advanced chronic liver diseases (ACLD) and is often associated with severe complications leading to increased morbidity and mortality. Currently, the gold standard for the evaluation of the severity of PHT is the hepatic venous-pressure gradient (HVPG). The disadvantage of using the HVPG, besides the availability of the technique only in referral centres, is in the case of patients with vascular liver disorders because the HVPG underestimates the severity of PHT. Recent studies have evaluated the feasibility of the pressure gradient measurement through endoscopic transgastric and transhepatic access using special kit with a 25-gauge FNA needle (Cook Medical, Winston-Salem, NC, USA) and a compact manometer (Cook Medical, Bloomington, Ind, USA) that has the disadvantage of high purchase cost, no tracing of pressure possible and has not yet been properly correlated with the gold standard HVPG measurement or PPG measurement thus limiting its use in current practice. The aim of the study is 1. to assess and compare the correlations in the porto-systemic gradient measurement between a) direct portal vein puncture during TIPS insertion, b) direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound procedure and c) indirect portal vein pressure measurements using the interventional radiology based hepatic HVPG procedure in patients with cirrhosis submitted to TIPS procedure for complications of portal hypertension and 2. To evaluate and compare the porto-systemic gradient obtained by direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound and indirect measurement through HVPG measuring in patients with presinusoidal hypertension and those with portal vein thrombosis.
详细描述
Number of patients needed to be included:
To achieve the first primary objective, the investigators will include 20 patients. To achieve the second primary objective, 30 patients will be included, with presinusoidal portal hypertension and patients with non-cirrhotic portal vein thrombosis or portal vein thrombosis in the context of cirrhosis. As non-cirrhotic portal hypertension is a lesser frequent type of portal hypertension, the number needed to be included will be sufficient.
Duration of the Study and Patient Participation:
Patient enrolment is expected to be completed within 24 months of study initiation. Total study duration is expected to be 26 months. Patients are expected to participate in this study for 7 days after the study procedure. Patients who meet one or more exclusion criteria during evaluation with EUS will be followed through procedural timepoint.
Patient Consent Patients who meet the inclusion criterion and none of the exclusion criteria will be invited to participate in this study. Patients eligible for enrolment will have the clinical study explained to them and each patient who agrees to participate will sign and date an informed consent document prior to the procedure or any study-specific testing or assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cirrhosis undergoing TIPS placement and patients with presinusoidal portal hypertension and patients with portal vein thrombosis
排除标准
- •Patient is < 18 or > 85 years of age
- •Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- •Patient is unwilling or unable to sign and date the informed consent
- •Patient for whom endoscopic procedures are contraindicated
- •Patients for whom propofol general anesthesia is contraindicated
- •Previous transjugular intrahepatic or surgical portosystemic shunt
- •Previous total or partial splenectomy
- •Known history of spontaneous bacterial peritonitis (SBP) within the last three months irrespective of treatment for SBP
- •Patients with known infection which is not controlled by medical intervention
- •Severe Portopulmonary hypertension contraindicating TIPS placement
- •Cardiac decompensation
- •Cholestatic liver disease
- •Patients with current advanced hepatocellular carcinoma (HCC)
- •Emergent salvage TIPS placement in patients with failure to control bleeding
- •Severe coagulopathy
- •Anatomic abnormalities of the hepatic vasculature that prevent access to the intrahepatic portion of the portal vein or hepatic veins
- •Evidence of active gastrointestinal bleeding
- •If the volume of ascites in the path of the needle prevents apposition of the gastrointestinal tract and liver
- •Allergies to iodine contrast
结局指标
主要结局
Correlation of the porto systemic pressure gradient measured by EUS and TIPS
时间窗: 1 year
in the first 12 months, patients enrolled will perform EUS and TIPS placement; measurement will be done according to protocol
Correlation of the porto systemic pressure gradient and portal hypertension signs
时间窗: 1 year
in the next 12 months, patients meeting criteria will perform EUS pressure assessment and detection of varices
Correlation of the hepatic venous pressure gradient and portosystemic pressure gradient
时间窗: 1 year
in the first 12 month, patients enrolled will perform EUS and TIPS placement; measurement will be done according to protocol
次要结局
未报告次要终点
研究者
Andrada Seicean
Clinical Professor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor