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

NCT07252570 | Completed

• 1 other identifier: 25Radio01
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Portal vein stent patency.

  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 Outcomes (3)

• Clinical efficacy (physiological parameter) of portal vein stenting

  From stent placement until death or loss to follow-up to 110 months.

• Safety of portal vein stenting.

  From procedure date until last follow-up to 110 months and graded according to SIR 2017 classification

• Technical success

  From stent placement start to completion portography (1 hour).

Study Arms (1)

Patients with malignant portal vein stenosis/occlusion treated by stent

Device: Transhepatic portal vein stent implantation

Interventions

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.

Patients with malignant portal vein stenosis/occlusion treated by stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Pancreatic Neoplasms; Hypertension, Portal

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: November 26, 2025
• Study Start: April 8, 2004
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-09

Locations

FR (1)