Expanding the Therapeutic Landscape of Post-TIPS Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Development of post-TIPS overt HE within 6 months after TIPS placement
研究概览
简要总结
The placement of TIPS (transjugular intrahepatic portosystemic shunt) is the most effective strategy to treat complications of portal hypertension. However, the threat of developing post-TIPS complications diminishes its use and applicability. Hepatic encephalopathy (HE) is the most feared and frequent post-TIPS complication, affecting between 25-54% of patients. Available treatments against HE are only partially effective. Therefore, the best existing strategy is to accurately select patients for TIPS excluding those presenting known high risk factors associated to post-TIPS HE. Despite applying this approach, the incidence of post-TIPS HE still remains very high. The investigators hypothesize that a better identification of risk factors for post-TIPS HE, together with the introduction of therapeutic interventions modulating pathophysiological mechanisms involved in post-TIPS HE development - among which sarcopenia stands out- would lead to a reduction in the incidence of HE and, eventually, to an increase in the number of patients benefiting from TIPS.
Thus, our project is aimed at
- Demonstrate that a 12 weeks lifestyle intervention based on resistance training and nutritional counseling can reduce sarcopenia and, ultimately, post-TIPS HE.
- To study predictive factors of post-TIPS HE, focusing on the role of factors that have never been evaluated in the setting of TIPS: gut microbiome and cognitive function
详细描述
1.- To evaluate the impact of a 12 weeks lifestyle intervention aimed to reduce sarcopenia in post-TIPS hepatic encephalopathy development
The first aim of the study will be approached by an open-label multicenter two arms randomized clinical trial, conducted in Hospital Clínic de Barcelona, Hospital Universitario Ramón y Cajal and Hospital Gregorio Marañón.
All cirrhotic patients submitted for elective TIPS in any of these three hospitals will be eligible. Patients fulfilling inclusion criteria and willing to participate will provide written informed consent and will be randomized to intervention or observational group in a 1:1 ratio. The randomization sequence will be generated by computer. The coded treatment assignment will be kept at the coordinating center in sealed, consecutively numbered, opaque envelopes.
All TIPS procedures will be carried out using PFTE-covered stents and using a stepwise dilatation ideally aiming at a final GPP between 10 and 12 mmHg (below 12 mmHg to protect from portal hypertension, over 10 mmHg to avoid post-TIPS HE).
Follow-up visits will be scheduled at 4 weeks, 12 weeks and 6 months post-TIPS. Patients will be followed up until death, liver transplantation or 6 months after TIPS placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the intervention (physical therapy and nutritional optimization) there is no masking in this study
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
- •All cirrhotic patients submitted for elective TIPS
排除标准
- •Contraindication for TIPS placement, contraindication for physical therapy
结局指标
主要结局
Development of post-TIPS overt HE within 6 months after TIPS placement
时间窗: 6 months
Overt HE will be defined if any grade from 2 to 4 of West Haven Criteria are present: grade 2, fatigue, apathy, flapping tremor, ataxia, slurred speech; grade 3, somnolence, marked disorientation, rigor, stupor; grade 4, coma.
次要结局
- development of portal hypertension complications during follow-up;(6 months)
- effects on sarcopenia(6 months)
- need of admission(6 months)
- 6 months mortality;(6 months)
- development of a second episode of overt HE within the first 6 month(6 months)
- time to development of either overt or minimal HE(6 months)
- percentage of follow-up days spent in the hospital(6 months)
- development of minimal HE within the first 6 months(6 months)
研究者
Anna Baiges
Principal Investigator
Hospital Clinic of Barcelona