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临床试验/NCT07252570
NCT07252570已完成不适用

Portal Vein Stenting for Malignant Obstruction: Feasibility, Safety, and Clinical Outcomes

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2004年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Portal vein stent patency.

研究概览

简要总结

Introduction:

Pre-hepatic portal hypertension of malignant origin can lead to severe complications such as refractory ascites or gastrointestinal bleeding, significantly impairing patients' quality of life. Available therapeutic options are mainly symptomatic and do not address the venous obstruction. Portal vein stenting represents a minimally invasive alternative, which remains poorly studied in this setting. The aim of our study was to evaluate portal stent patency, as well as clinical efficacy and safety, in patients with symptomatic malignant stenosis or occlusion of the portal system. Methods: The team conducted a retrospective cohort study including 63 consecutive patients treated between April 2004 and March 2024 at CHU l'Archet and CAL Nice for symptomatic malignant stenosis or occlusion of the portal system. All patients underwent percutaneous transhepatic portal vein stenting with uncovered self-expandable metallic stents. The primary endpoint was stent patency, defined as the interval between implantation and the occurrence of an occlusion confirmed by imaging or end of follow-up. Secondary endpoints included technical success, clinical success (improvement of portal hypertension signs), and the occurrence of adverse events, graded according to the 2017 SIR classification.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • •Age ≥ 18 years.
  • •Presence of symptoms related to portal hypertension (e.g., refractory ascites, gastrointestinal bleeding).
  • •Imaging evidence of stenosis or obstruction of the portal venous system (main portal vein, superior and/or inferior mesenteric vein, spleno-mesenteric confluence, and/or splenic vein).

排除标准

  • •Obstruction or stenosis secondary to a malignant/neoplastic process.

结局指标

主要结局

Portal vein stent patency.

时间窗: From stent placement until death or loss to follow-up to 110 months.

Stent patency was assessed using cross-sectional imaging and/or Doppler ultrasound.

次要结局

  • Clinical efficacy (physiological parameter) of portal vein stenting(From stent placement until death or loss to follow-up to 110 months.)
  • Safety of portal vein stenting.(From procedure date until last follow-up to 110 months and graded according to SIR 2017 classification)
  • Technical success(From stent placement start to completion portography (1 hour).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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