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Efficacy and Safety of Variceal Embolization Combined With Partial Splenic Artery Embolization for Variceal Bleeding in Cavernous Transformation of Portal Vein.

NCT07310316 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-12-30

No results posted yet for this study

Summary

The management of variceal bleeding in patients with cavernous transformation of portal vein (CTPV) generally adheres to the principles applied to cirrhotic portal hypertension, including pharmacological therapy, endoscopic intervention, transjugular intrahepatic portosystemic shunt (TIPS), and surgery. However, the distinct hemodynamic profile caused by portal vein occlusion in CTPV introduces specific therapeutic challenges: 1. Conventional pharmacological and endoscopic treatments often yield suboptimal outcomes. 2. Splenectomy with periesophagogastric devascularization is associated with significant complication rates and elevated perioperative mortality. 3. The feasibility of TIPS depends on sufficient portal venous inflow to ensure stent patency, while also carrying a risk of hepatic encephalopathy. Based on these considerations, the investigators hypothesize that for patients with extensive portal thrombosis and inadequate portal inflow who are ineligible for TIPS, a combination of variceal embolization and partial splenic artery embolization may reduce portal pressure and decrease the risk of esophagogastric variceal bleeding. To evaluate this hypothesis, a retrospective cohort study has been designed.

Conditions

  • Cavernous Transformation of Portal Vein
  • Gastroesophageal Varices Bleeding

Interventions

PROCEDURE

Variceal Embolization Combined With Partial Splenic Artery Embolization

Variceal Embolization : 1. Under ultrasound guidance, a branch of the portal or splenic vein was percutaneously punctured. 2. Angiography was performed with pressure measurements to evaluate the varices. 3. The varices were embolized using spring coils and/or tissue adhesive . 4. Post-embolization angiography was subsequently performed to assess the technical outcome. Partial Splenic Artery Embolization : 1. The right femoral artery was punctured using the Seldinger technique. 2. Digital subtraction angiography (DSA) was performed following selective catheterization of the splenic artery to delineate its anatomy and branching pattern. 3. Embolic particles were injected under fluoroscopic guidance. 4. Intermittent follow-up splenic arteriography was performed, on the basis of the reduction in blood flow velocity, to evaluate the degree of embolization. 5. The range of the embolization was targeted at 50-60% of the splenic parenchyma.

Sponsors & Collaborators

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Jun Tie · Air Force Military Medical University, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07310316 on ClinicalTrials.gov