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Occlusive Portal Vein Thrombosis (OPVT)NCT07666256

Mesenteric Vein Access for OPVT-Related Recurrent Variceal Bleeding: An Ambispective Cohort

A study testing Percutaneous mesenteric vein-assisted interventional treatment in people with Occlusive Portal Vein Thrombosis (OPVT) and Cavernous Transformation of Portal Vein, run by Air Force Military Medical University, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Occlusive portal vein thrombosis (OPVT) is defined as complete thrombosis of the main portal vein trunk, resulting in total interruption of portal venous inflow and representing the most severe form of portal vein thrombosis. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Percutaneous mesenteric vein-assisted interventional treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
1 Jul 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed OPVT, as demonstrated by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).
  • History of at least two episodes of esophagogastric variceal bleeding.
  • Ineligible for, or have previously failed, conventional transjugular intrahepatic portosystemic shunt (TIPS) or percutaneous transhepatic/transsplenic access approaches, including but not limited to extensive thrombosis of intrahepatic portal vein branches, prior splenectomy, or previous unsuccessful attempts.
  • Child-Pugh score ≤12, with anticipated tolerance of the interventional procedure.

Who cannot join

  • Thrombosis or severe stenosis of the superior mesenteric vein (SMV), precluding its use as a percutaneous access route.
  • Severe cardiac, pulmonary, or renal insufficiency that precludes tolerance of the procedure.
  • Uncorrectable coagulopathy.
  • Life expectancy <3 months, or inability to comply with scheduled follow-up visits.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Air Force Medical University

    Xi'an, Shaanxi, 710032

    Jun Tie, M.D.,Ph.D., +862984771537, tiejun7776@163.com

Other trials in China

About this study

Official title: Percutaneous Mesenteric Vein Access for Interventional Management of Recurrent Variceal Bleeding in Occlusive Portal Vein Thrombosis: An Ambispective Cohort Study

Occlusive portal vein thrombosis (OPVT) is defined as complete thrombosis of the main portal vein trunk, resulting in total interruption of portal venous inflow and representing the most severe form of portal vein thrombosis. A small proportion of patients may remain asymptomatic for prolonged periods because of sufficient collateral compensation; however, most develop complications of portal hypertension when collateral flow is inadequate, including gastroesophageal variceal bleeding and ascites. Among these, gastroesophageal variceal bleeding is the most life-threatening, and its management is more challenging-with a higher risk of rebleeding-than in patients without portal vein thrombosis.

Occlusive portal vein thrombosis (OPVT) is defined as complete thrombosis of the main portal vein trunk, resulting in total interruption of portal venous inflow and representing the most severe form of portal vein thrombosis. A small proportion of patients may remain asymptomatic for prolonged periods because of sufficient collateral compensation; however, most develop complications of portal hypertension when collateral flow is inadequate, including gastroesophageal variceal bleeding and ascites. Among these, gastroesophageal variceal bleeding is the most life-threatening, and its management is more challenging-with a higher risk of rebleeding-than in patients without portal vein thrombosis.

Read more

Transjugular intrahepatic portosystemic shunt (TIPS) is an effective minimally invasive therapy for portal hypertension-related complications; however, in OPVT, technical feasibility largely depends on successful portal vein recanalization. To improve TIPS success in OPVT, our group-together with domestic and international investigators-has explored several adjunctive access routes and technical modifications, including percutaneous transhepatic or transsplenic portal vein recanalization TIPS (PVR-TIPS); transjugular portal cavernous collateral-caval shunt (TCCS); transjugular mesenteric-caval shunt (TMCS); transjugular spleno-caval shunt (TSCS); and surgically assisted hybrid procedures. Although these strategies have improved technical success rates to some extent, their applicability remains limited. In patients with extensive thrombosis involving intrahepatic portal vein branches, in those without a feasible splenic venous puncture route, or in patients with prior splenectomy, percutaneous transhepatic and transsplenic approaches are often not possible. Moreover, in patients with poor hepatic reserve and/or ascites, laparotomy-assisted hybrid procedures substantially increase invasiveness and perioperative risk.

In this context, the present project aims to systematically investigate and evaluate ultrasound-guided percutaneous mesenteric vein (MV) puncture as an adjunctive access strategy for interventional treatment of OPVT. This technique uses ultrasound-guided percutaneous puncture of the MV to establish antegrade portal venous access, thereby facilitating subsequent portal vein recanalization and/or shunt creation.

Read the detailed description

Occlusive portal vein thrombosis (OPVT) is defined as complete thrombosis of the main portal vein trunk, resulting in interruption of portal venous inflow and representing a severe form of portal vein thrombosis. Although some patients may remain asymptomatic for prolonged periods because of collateral compensation, many develop clinically significant portal hypertension when collateral flow is inadequate-most notably gastroesophageal variceal bleeding and ascites. Gastroesophageal variceal bleeding is a major cause of morbidity and mortality and is often more difficult to control, with a higher risk of rebleeding, than variceal bleeding in patients without portal vein thrombosis.

Transjugular intrahepatic portosystemic shunt (TIPS) is an established minimally invasive therapy for complications of portal hypertension. In OPVT, however, technical feasibility often hinges on successful portal vein recanalization. Multiple adjunctive techniques have been developed to improve feasibility in selected patients, including percutaneous transhepatic or transsplenic portal vein recanalization TIPS (PVR-TIPS), portal cavernous collateral-caval shunt procedures, mesenteric-caval or spleno-caval shunts, and surgically assisted hybrid approaches. Despite these advances, a meaningful subset of patients remain poor candidates because of extensive intrahepatic portal branch thrombosis, absence of a feasible splenic puncture route, prior splenectomy, or prohibitive risk for laparotomy-assisted hybrid procedures (e.g., in patients with limited hepatic reserve and/or ascites).

This study will evaluate ultrasound-guided percutaneous mesenteric vein (MV) puncture as an adjunctive access strategy to enable interventional decompression of the portal venous system in OPVT. Using real-time ultrasound, percutaneous MV access is obtained to establish an antegrade working channel. This channel is then used to facilitate portal vein recanalization and/or shunt creation when standard access routes are not feasible or have failed.

Study design and setting: Ambispective, exploratory, single-center clinical study.

Population: Patients with imaging-confirmed OPVT and recurrent gastroesophageal variceal bleeding, particularly those in whom conventional interventional access routes (e.g., transjugular-only approaches, percutaneous transhepatic access, or transsplenic access) are limited, infeasible, or have been unsuccessful.

Intervention (Stepwise Intra-procedural Strategy)

After establishing MV access under ultrasound guidance, operators will follow a predefined escalation algorithm based on intra-procedural anatomy and technical feasibility:

MV-assisted PVR-TIPS (preferred): Antegrade catheter/guidewire manipulation via MV access to attempt recanalization of the occluded main portal vein trunk. A catheter or balloon may be positioned as a target to facilitate completion of a standard TIPS via the transjugular route.

MV-assisted collateral-to-caval shunt (secondary): If main portal vein recanalization is not achievable, selective catheterization of an eligible collateral (e.g., diameter ≥6 mm) may be performed, with target-marker assistance to create a collateral-to-inferior vena cava shunt via the transjugular route.

Extrahepatic MV-to-caval shunt (backup): If neither main portal vein recanalization nor a suitable collateral is available, an extrahepatic MV-to-inferior vena cava shunt tract may be created through the established MV access as an alternative portal decompression strategy.

Outcomes (Overview) The study will assess: (1) technical feasibility (e.g., successful MV access; successful creation of a functioning shunt via any pathway), (2) procedural safety (peri-procedural and follow-up complications), and (3) clinical effectiveness, including control of portal hypertension-related bleeding (e.g., rebleeding during follow-up) and other manifestations of portal hypertension, as applicable.

Being tested
Percutaneous mesenteric vein-assisted interventional treatment
Keywords
Occlusive portal vein thrombosis (OPVT), Cavernous Transformation of Portal Vein, Esophageal and gastric variceal bleeding, Transjugular intrahepatic portosystemic shunt, Superior Mesenteric Vein
Medical subject headings
Portal Vein, Cavernous Transformation Of

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous mesenteric vein-assisted interventional treatmentProcedure or surgery

    Intervention (stepwise intra-procedural strategy). After MV access is established under ultrasound guidance, operators will follow a predefined escalation algorithm based on anatomy and feasibility:

    MV-assisted PVR-TIPS (preferred): Using antegrade catheter/guidewire manipulation via MV access, attempt recanalization of the occluded main portal vein trunk. A catheter or balloon may be positioned as a target to complete standard TIPS via the transjugular route.

    MV-assisted collateral-to-caval shunt (secondary): If main portal vein recanalization is not achievable, catheterize an eligible collateral (e.g., ≥6 mm) and, with target-marker assistance, create a collateral-to-inferior vena cava shunt via the transjugular route.

    Extrahepatic MV-to-caval shunt (backup): If neither main portal vein recanalization nor a suitable collateral is available, create an extrahepatic MV-to-inferior vena cava shunt tract through MV access as an alternative portal decompression strategy.

Study groups in NCT07666256
Study groupRoleWhat they receive
Percutaneous mesenteric vein-assisted interventional treatmentExperimentalEligible patients include those with imaging-confirmed OPVT and recurrent gastroesophageal variceal bleeding, particularly when conventional interventional access routes (e.g., transjugular-only approaches, percutaneous transhepatic access, or transsplenic access) are limited, infeasible, or have failed. Under real-time ultrasound guidance, percutaneous mesenteric vein (MV) access is obtained to establish an antegrade working channel, which is then used to facilitate portal vein recanalization and/or shunt creation.
Receives: Procedure: Percutaneous mesenteric vein-assisted interventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical success of the index procedure (overall)

    Successful creation of a functioning portosystemic shunt using the study strategy (MV-assisted PVR-TIPS, MV-assisted collateral-to-caval shunt, or extrahepatic MV-to-caval shunt), confirmed by completion angiography demonstrating shunt patency/flow and effective portal decompression as assessed intra-procedurally per operator judgment and standard imaging criteria.

    Measured: During the procedure (index hospitalization)

  2. Safety-major procedure-related adverse events

    Incidence of major adverse events related to MV puncture and/or shunt creation (e.g., clinically significant intraperitoneal hemorrhage, bowel/mesenteric injury, sepsis, procedure-related death, or other events meeting predefined serious adverse event criteria).

    Measured: From procedure through 30 days post-procedure.

Secondary outcomes (4)
  1. Variceal rebleeding

    Incidence of recurrent gastroesophageal variceal bleeding after the index procedure, defined clinically (e.g., hematemesis/melena with endoscopic and/or imaging confirmation when available) and requiring hospital presentation, transfusion, endoscopic therapy, radiologic intervention, or resulting in death.

    Measured: 6 months post-procedure.

  2. Shunt patency (primary patency)

    Proportion of patients with a patent shunt without need for re-intervention, assessed by Doppler ultrasound and/or contrast-enhanced CT/MR venography per the follow-up schedule.

    Measured: 6 months post-procedure.

  3. Hepatic encephalopathy (new onset or worsening)

    Incidence and severity of hepatic encephalopathy after the procedure, graded using a standardized clinical scale per institutional practice (e.g., West Haven criteria) and requiring initiation/escalation of therapy and/or hospitalization.

    Measured: From procedure through 6 months post-procedure.

  4. Overall survival

    All-cause mortality following the index procedure.

    Measured: 6 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07666256
Sponsor's protocol ID
KY20262173-F-1
Status last verified
Jun 2026
First submitted
18 Jun 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous mesenteric vein-assisted interventional treatment in people with Occlusive Portal Vein Thrombosis (OPVT) and Cavernous Transformation of Portal Vein, run by Air Force Military Medical University, China at 1 site in China.

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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Jun 2026. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Tie (+862984771537, tiejun7776@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success of the index procedure (overall) (time frame: During the procedure (index hospitalization)). The study lists 2 primary outcomes in all. 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 24 Jun 2026.

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