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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAir Force Military Medical University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years;

Diagnosis of cavernous transformation of the portal vein (CTPV) confirmed by at least one imaging modality (ultrasonography, CT, or MRI);

Portal vein thrombosis (PVT) extending to the splenic vein (SV) and superior mesenteric vein (SMV);

History of portal hypertension complicated by variceal bleeding, with recurrent bleeding despite pharmacological and endoscopic therapies;

Disqualifiers

Concomitant malignant tumor;

Active infection

Trial design

Design model

Single group

Treatments tested in this trial

  • Variceal Embolization Combined With Partial Splenic Artery Embolization

    Procedure/Surgery

    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.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: CTPVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative incidence of gastroesophageal variceal rebleeding.

Clinically significant rebleeding is defined in accordance with the Baveno V consensus criteria and is identified by recurrence of melena or hematemesis accompanied by any of the following: a) requirement for hospitalization; b) need for blood transfusion; c) hemoglobin decrease of ≥3 g/dL; or d) death within 6 weeks.

Time frame
12 months

Secondary outcomes

1

All-cause rebleeding

Time frame
12 months
2

New or worsening ascites

Defined as an increase of at least one grade in ascites severity on ultrasound (grading criteria: Grade 0 = none, Grade 1 = mild, Grade 2 = moderate, Grade 3 = large), or persistent ascites requiring paracentesis.

Time frame
12 months
3

Incidence of overt hepatic encephalopathy

Hepatic encephalopathy is classified according to the 2022 European Association for the Study of the Liver (EASL) Clinical Practice Guidelines using the West-Haven criteria. Overt hepatic encephalopathy is defined as grade II or higher.

Time frame
12 months
4

Liver function

Liver function will be evaluated using the Child-Pugh score (based on bilirubin, albumin, INR, ascites, and hepatic encephalopathy) and the Model for End-Stage Liver Disease (MELD) score. Child-Pugh Score A to C ( scores ranging from 5 to 15), with higher scores indicating more severe liver dysfunction and a worse prognosis. Child-Pugh Score Grading : Class A: 5-6 scores;Class B: 7-9 scores;Class C: 10-15 scores. MELD = 3.78 × Ln\[serum total bilirubin (mg/dL)\] + 11.2 × Ln\[INR\] + 9.57 × Ln\[serum creatinine (mg/dL)\] + 6.4 × (etiology: 0 for cholestatic or alcoholic, 1 for other). Risk Stratification : High Risk: \>18 scores; Intermediate Risk: 15-18 scores; Low Risk: ≤14 scores.

Time frame
12 months

Other outcomes

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