2024-512040-28-01招募中4 期
The PEARL trial: Prevention of hepatic Encephalopathy by administration of Rifaximin and Lactulose in patients with liver cirrhosis undergoing placement of a transjugular intrahepatic portosystemic shunt: a multi-centre randomized, double blind, placebo controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 10
- 主要终点
- Primary endpoint is the development of OHE within three months after TIPS placement determined by the West Haven criteria.
研究概览
简要总结
To assess the incidence of post-TIPS OHE within the first three months after prophylactic administration of lactulose and rifaximin versus placebo in patients who undergo Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Elective TIPS placement for refractory ascites or recurrent variceal bleeding: • Recurrent tense ascites and one or more of the following criteria: i. Not responding to the maximal dose of diuretics (400mg spironolactone and 160mg furosemide). ii. Kidney insufficiency (Creatinine > 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium < 125 mmol/L, Potassium > 5.5 mmol/L) induced by diuretics. iv. Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps). • (Recurrent) variceal bleeding, not responsive to treatment with endoscopic band ligation and/or beta-blockers, with a high risk of failure of endoscopic treatment: i. Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis or ii. Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy
- •Age ≥18 years
- •Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
- •Signed informed consent
排除标准
- •Any absolute contraindications for TIPS placement: a. History of hepatic encephalopathy grade II-IV without precipitating factor b. Heart failure NYHA ≥ grade 3 c. Hepatocellular carcinoma (multifocal or large or centrally located) d. Systemic infection / sepsis e. Severe pulmonary hypertension NL 68205.018.18 / The PEARL trial Version number: 1.9.1, 23 January 2024 21 of 58 f. Unrelieved bile duct obstruction g. Technically not feasible h. Poor liver function (MELD score > 20)
- •Patients refusing or unable to sign informed consent
- •Use of ciclosporin
- •Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
- •Age > 80 years
- •Non-cirrhotic portal hypertension
- •Portal vein thrombosis (main trunk)
- •Current or recent (<3 months) use of rifaximin
- •Overt neurologic diseases such as Alzheimer’s disease, Parkinson’s disease
- •Pregnant or breastfeeding women
结局指标
主要结局
Primary endpoint is the development of OHE within three months after TIPS placement determined by the West Haven criteria.
Primary endpoint is the development of OHE within three months after TIPS placement determined by the West Haven criteria.
次要结局
- Secondary endpoints include 90-day mortality; development of a second episode of OHE within the first three months; development of OHE in the period between three and twelve months after TIPS placement; development of MHE between TIPS placement and twelve months post-placement; time to development of OHE or MHE episodes; the increase in PHES, S-ANT1 score and LFI compared to baseline.
研究者
DJ van Doorn
Scientific
Amsterdam UMC Stichting
研究点 (10)
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