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

NCT07666256 | Not Yet Recruiting DMC

• 1 other identifier: KY20262173-F-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Occlusive Portal Vein Thrombosis (OPVT); Cavernous Transformation of Portal Vein; Gastroesophageal Varices Bleeding

Keywords

Occlusive portal vein thrombosis (OPVT); Cavernous Transformation of Portal Vein; Esophageal and gastric variceal bleeding; Transjugular intrahepatic portosystemic shunt; Superior Mesenteric Vein

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  From procedure through 30 days post-procedure.

Secondary Outcomes (4)

• Variceal rebleeding

  6 months post-procedure.

• Shunt patency (primary patency)

  6 months post-procedure.

• Hepatic encephalopathy (new onset or worsening)

  From procedure through 6 months post-procedure.

• Overall survival

  6 months post-procedure

Study Arms (1)

Percutaneous mesenteric vein-assisted interventional treatment

EXPERIMENTAL

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

Interventions

Percutaneous mesenteric vein-assisted interventional treatment PROCEDURE

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.

Percutaneous mesenteric vein-assisted interventional treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Portal Vein, Cavernous Transformation Of

Central Study Contacts

Jun Tie

CONTACT

+862984771537; tiejun7776@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical research

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)