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

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Portal Hypertension
Biliary Tract Neoplasms
Portal Vein Thrombosis
Pancreatic Neoplasm

Treatments

Device: Transhepatic portal vein stent implantation

Study type

Observational

Funder types

Other

Identifiers

NCT07252570
25Radio01

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

63 participants in 1 patient group

Patients with malignant portal vein stenosis/occlusion treated by stent
Treatment:
Device: Transhepatic portal vein stent implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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