Portal Vein Stenting for Malignant Obstruction: Feasibility, Safety, and Clinical Outcomes
NCT ID: NCT07252570
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2004-04-08
2025-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with malignant portal vein stenosis/occlusion treated by stent
Transhepatic portal vein stent implantation
The intervention consisted of percutaneous transhepatic implantation of a self-expanding metallic stent in the portal vein to treat malignant symptomatic portal vein stenosis or occlusion. Patients were selected on the basis of clinical complications related to portal hypertension, such as refractory ascites or gastrointestinal bleeding. The procedure aimed to restore portal vein patency and reduce symptoms. Stents of different lengths (40 mm, 60 mm, or 80 mm) were deployed depending on the anatomical extent of the obstruction. All procedures were performed by interventional radiologists under image guidance. Patients were subsequently followed for technical success, stent patency, clinical efficacy, and procedure-related safety.
Interventions
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Transhepatic portal vein stent implantation
The intervention consisted of percutaneous transhepatic implantation of a self-expanding metallic stent in the portal vein to treat malignant symptomatic portal vein stenosis or occlusion. Patients were selected on the basis of clinical complications related to portal hypertension, such as refractory ascites or gastrointestinal bleeding. The procedure aimed to restore portal vein patency and reduce symptoms. Stents of different lengths (40 mm, 60 mm, or 80 mm) were deployed depending on the anatomical extent of the obstruction. All procedures were performed by interventional radiologists under image guidance. Patients were subsequently followed for technical success, stent patency, clinical efficacy, and procedure-related safety.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU de NICE
Nice, Alpes Maritimes, France
Countries
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Other Identifiers
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25Radio01
Identifier Type: -
Identifier Source: org_study_id
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