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Completed

NCT Number: NCT07252570

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

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.

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Key information

Conditions

Biliary Tract Neoplasms Biliary Tract Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypertension, Portal Liver Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasm Pancreatic Neoplasms Portal Hypertension Portal Vein Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transhepatic portal vein stent implantation

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2004
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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