TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- overall survival after TIPS placement
研究概览
简要总结
Porto-sinusoidal Vascular Disease (PSVD) is characterized by a portal hypertension (PH) without cirrhosis. This can induce PH complications, like digestive hemorrhage from esophageal or gastric varices, ascites, or even portal thrombosis. Due to the rarity of MVPS, the treatment of complications of portal hypertension is modeled on the methods used in cirrhotic portal hypertension with non-cardio-selective beta blockers, endoscopic ligations or diuretics in first line therapy, as proposed by the Baveno VII recommendations. In complicated or refractory forms of PH in PSVD, the place of TIPS is also discussed, as in the field of cirrhosis. However, the experience of TIPS in PSVD is limited, reported in case reports and small specifically dedicated series. No predictive factors for survival or recurrence and tolerance were well known. A larger study with control group is needed in order to better know the right time and the right indication for the use of TIPS in complicated PH PSVD-related.
The study will be retrospective, multicentric involving tertiary university French centers, expert in the management of TIPS. Patients white TIPS-PSVD will be compared with historical patients with TIPS-cirrhose, matched on age, sexe, indication of TIPS. The study will not comprise new intervention, only observational in a real life condition
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •PSVD group :
- •Patient with PSVD according VALDIG criteria
- •TIPS for digestive hemorrhage on portal hypertension
- •TIPS for refractory ascite
- •TIPS for portal vein thrombosis
- •Cirrhosis group with PH : (appaired by age, sexe, type of PH complications)
- •Confirmed cirrhosis with :
- •TIPS for digestive hemorrhage on portal hypertension
- •TIPS for refractory ascite
- •TIPS for portal vein thrombosis
排除标准
- •no PSVD confirmed diagnosis
- •Budd Chiari syndrome
- •Rendu Osler disease; Heart failure
- •Fontan; Sarcoïdosis
- •Schistosomiase
- •Congenitale liver fibrosis
- •Abernathy syndrome
- •Tumor infiltration by lymphoma
- •Bone graft
结局指标
主要结局
overall survival after TIPS placement
时间窗: at 5 years
次要结局
- free TIPS dysfunction survival(at 5 years)
- free portal hypertension hemorrhage recurrence survival(at 5 years)
- free ascite recurrence survival(at 5 years)
- complication of TIPS placement at D0(at 5 years)
