About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 design
Treatments tested in this trial
- Percutaneous mesenteric vein-assisted interventional treatment
Treatment groups
Sponsors and collaborators
Air Force Military Medical University, China
Lead sponsor
The First Affiliated Hospital of Air Force Medicial University
Sponsor institution