An interventional study of Percutaneous mesenteric vein-assisted interventional treatment in Occlusive Portal Vein Thrombosis (OPVT), Cavernous Transformation of Portal Vein and Gastroesophageal Varices Bleeding, sponsored by Air Force Military Medical University, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment
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.
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.
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.
Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible 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.
Procedure: Percutaneous mesenteric vein-assisted interventional treatment
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.
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.
Time frame: During the procedure (index hospitalization)
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).
Time frame: From procedure through 30 days post-procedure.
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.
Time frame: 6 months post-procedure.
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.
Time frame: 6 months post-procedure.
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.
Time frame: From procedure through 6 months post-procedure.
Overall survival
All-cause mortality following the index procedure.
Time frame: 6 months post-procedure
Plan to share: Yes
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Start is estimated for Jul 2026; primary completion for Jun 2028, 23 months later.
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Portal Vein, Cavernous Transformation Of
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