Biliary Tract NeoplasmsNCT07252570
Portal Vein Stenting for Malignant Obstruction: Feasibility, Safety, and Clinical Outcomes
An observational study of Biliary Tract Neoplasms and Pancreatic Neoplasm, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Neoplasms, Pancreatic Neoplasm, Portal Hypertension
- What is being tested?
- Transhepatic portal vein stent implantation
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2004to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Obstruction or stenosis secondary to a malignant/neoplastic process.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Transhepatic portal vein stent implantation
- Medical subject headings
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transhepatic portal vein stent implantationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with malignant portal vein stenosis/occlusion treated by stent | Not described Receives: Device: Transhepatic portal vein stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal vein stent patency.
Stent patency was assessed using cross-sectional imaging and/or Doppler ultrasound.
Measured: From stent placement until death or loss to follow-up to 110 months.
Secondary outcomes (3)
Clinical efficacy (physiological parameter) of portal vein stenting
Assessment was performed retrospectively using medical records, imaging studies, and follow-up endoscopy when available.
Measured: From stent placement until death or loss to follow-up to 110 months.
Safety of portal vein stenting.
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.
Measured: From procedure date until last follow-up to 110 months and graded according to SIR 2017 classification
Technical success
Successful stent implantation was defined as placement at the intended anatomical site with confirmed patency on completion portography.
Measured: From stent placement start to completion portography (1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start8 Apr 2004
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252570
- Sponsor's protocol ID
- 25Radio01
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Stenting for Malignant Obstruction: Feasibility, Safety, and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07252570
- Acronym / sponsor ID
- 25Radio01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Apr 2004 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant portal vein stenosis/occlusion treated by stent | – | Device: Transhepatic portal vein stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Obstruction or stenosis secondary to a malignant/neoplastic process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transhepatic portal vein stent implantationThe 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. | Device | Patients with malignant portal vein stenosis/occlusion treated by stent |
Primary outcome
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.
3 secondary outcomes
Clinical efficacy (physiological parameter) of portal vein stenting
Time frame: 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
Technical success
Time frame: From stent placement start to completion portography (1 hour).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Neoplasms and Pancreatic Neoplasm, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal vein stent patency. (time frame: From stent placement until death or loss to follow-up to 110 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.