Portal Vein Stenting for Malignant Obstruction: Feasibility, Safety, and Clinical Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Portal vein stent patency.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
- 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).)