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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07252570
Enrollment
63
Registered
2025-11-26
Start date
2004-04-08
Completion date
2025-01-01
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms, Pancreatic Neoplasm, Portal Hypertension, Portal Vein Thrombosis

Brief summary

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.

Interventions

DEVICETranshepatic 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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Portal vein stent patency.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.

Secondary

MeasureTime frameDescription
Clinical efficacy (physiological parameter) of portal vein stentingFrom stent placement until death or loss to follow-up to 110 months.Assessment was performed retrospectively using medical records, imaging studies, and follow-up endoscopy when available.
Safety of portal vein stenting.From procedure date until last follow-up to 110 months and graded according to SIR 2017 classificationProcedure-related adverse events were retrospectively collected from medical records and classified according to the Society of Interventional Radiology (SIR) complication grading system. Safety was assessed by recording the occurrence, type, and severity of adverse events following stent placement.
Technical successFrom stent placement start to completion portography (1 hour).Successful stent implantation was defined as placement at the intended anatomical site with confirmed patency on completion portography.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026