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

November 24, 2025 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06000
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of consecutive adult patients referred to the Interventional Radiology Department of Nice University Hospital (CHU l'Archet, France) between April 2004 and March 2024. All patients presented with symptomatic portal hypertension related to malignant portal venous stenosis or occlusion and were treated with percutaneous transhepatic portal vein stenting. Patients were identified retrospectively from institutional medical records.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with malignant portal vein stenosis/occlusion treated by stent
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portal vein stent patency.
Time Frame: 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.
From stent placement until death or loss to follow-up to 110 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2004

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25Radio01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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