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

A Retrospective Cohort Study : Efficacy and Safety of Variceal Embolization Combined With Partial Splenic Artery Embolization in the Treatment of Variceal Bleeding in Cavernous Transformation of Portal Vein.

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Varices Bleeding; Cavernous Transformation of Portal Vein
• Intervention / Treatment: Procedure: Variceal Embolization Combined With Partial Splenic Artery Embolization

Detailed Description

Cavernous transformation of the portal vein (CTPV) is primarily caused by portal vein thrombosis (PVT). It is characterized by the formation of a network of tortuous, dilated, and malformed venous channels around the obstructed portal vein-a morphology that macroscopically resembles a sponge, hence the name. While a minority of patients with well-developed collateral circulation may remain asymptomatic, most develop complications of portal hypertension, such as esophagogastric variceal bleeding, ascites, and hypersplenism. Variceal bleeding, in particular, is associated with acute onset and high mortality. The management of variceal bleeding in CTPV generally follows guidelines for cirrhotic portal hypertension, including pharmacological therapy, endoscopic treatment, transjugular intrahepatic portosystemic shunt (TIPS), and surgical intervention. However, the distinct hemodynamics resulting from portal vein occlusion pose specific therapeutic challenges:

1. Limited Efficacy of Conventional Pharmacological and Endoscopic Therapies: The chronic organic obstruction in CTPV renders pharmacological agents that reduce portal pressure-such as non-selective beta-blockers-largely ineffective, as they cannot adequately decrease pressure distal to the occlusion. Furthermore, the extensive and complex collateral circulation that develops (e.g., gastroesophageal varices, retroperitoneal venous networks) is often multifocal and highly interconnected. This makes it difficult for endoscopic band ligation or sclerotherapy to comprehensively address all potential bleeding sources. As a result, CTPV patients experience significantly higher rebleeding rates after endoscopic therapy compared to those with conventional portal hypertension.
2. Challenges of Splenectomy with Periesophagogastric Devascularization: Although this classic surgical procedure is used for variceal bleeding in standard portal hypertension, its application in CTPV is complicated by several factors. The spleen is often markedly enlarged and adherent to adjacent structures due to chronic congestion, and the splenic hilar vessels are tortuous and friable, increasing the risk of intraoperative hemorrhage. Moreover, the abundant collateral circulation requires the ligation of a much larger number of vessels than in typical cases. Incomplete devascularization can lead to rebleeding, while the extensive nature of the surgery-coupled with chronic malnutrition and reduced hepatic reserve-elevates the risks of infection, liver failure, and thrombosis, contributing to high perioperative mortality.
3. Limitations of TIPS: While TIPS has shown efficacy in selected CTPV patients with portal hypertension, its success depends on sufficient portal venous inflow to maintain stent patency. In cases with extensive thrombosis involving the splenic or superior mesenteric veins, inadequate inflow increases the risk of early stent thrombosis and shunt dysfunction. Additionally, TIPS carries a well-established risk of hepatic encephalopathy, necessitating careful patient selection, particularly in those with advanced liver dysfunction (Child-Pugh class C) or high baseline encephalopathy risk.

Evidence suggests that combined variceal embolization and partial splenic artery embolization achieves hemostatic outcomes comparable to modified TIPS in cirrhotic portal hypertension, with similar rebleeding rates. This dual interventional approach may also confer benefits in terms of liver function improvement and could be particularly advantageous for patients at high risk of hepatic encephalopathy or with significant liver impairment. Therefore, the investigators hypothesize that for CTPV patients with extensive portosystemic thrombosis and insufficient portal inflow who are unsuitable for shunt procedures, this combined embolization therapy may reduce portal pressure and mitigate the risk of esophagogastric variceal bleeding.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Tie, M.D.,Ph.D.; Phone Number: +862984771537; Email: tiejun7776@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Air Force Military Medical University
      • Contact: Jun Tie, M.D.,Ph.D.; Phone Number: +862984771537; Email: tiejun7776@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years;
2. Diagnosis of cavernous transformation of the portal vein (CTPV) confirmed by at least one imaging modality (ultrasonography, CT, or MRI);
3. Portal vein thrombosis (PVT) extending to the splenic vein (SV) and superior mesenteric vein (SMV);
4. History of portal hypertension complicated by variceal bleeding, with recurrent bleeding despite pharmacological and endoscopic therapies;
5. Treated with combined variceal embolization and partial splenic artery embolization;
6. Availability of at least one postoperative follow-up examination with documented clinical data and survival status.

Exclusion Criteria:

1. Concomitant malignant tumor;
2. Active infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CTPV; A minority of CTPV patients with well-established collateral circulation may remain asymptomatic. However, the majority develop complications of portal hypertension, such as esophagogastric variceal bleeding, ascites, and hypersplenism. Variceal bleeding in particular is characterized by acute onset and high mortality.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months
Liver transplantation-free survival	Defined as the time from the TIPS procedure to the end of follow-up, liver transplantation, or death.	12 months
All-cause rebleeding		12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Jun Tie, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Esophageal and gastric variceal bleeding; Cavernous Transformation of Portal Vein; Variceal Embolization; Partial Splenic Artery Embolization
• Additional Relevant MeSH Terms: Portal Vein, Cavernous Transformation Of
• Other Study ID Numbers: KY20252459-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No