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临床试验/NCT07163689
NCT07163689招募中不适用

TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年5月16日最近更新:

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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