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

NCT07310316 | Recruiting DMC

• 1 other identifier: KY20252459-F-1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cavernous Transformation of Portal Vein; Esophageal and gastric variceal bleeding; Variceal Embolization; Partial Splenic Artery Embolization

Outcome Measures

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.

  12 months

Secondary Outcomes (5)

• All-cause rebleeding

  12 months

• New or worsening ascites

  12 months

• Incidence of overt hepatic encephalopathy

  12 months

• Liver function

  12 months

• Liver transplantation-free survival

  12 months

Study Arms (1)

CTPV

EXPERIMENTAL

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

Interventions

Variceal Embolization Combined With Partial Splenic Artery Embolization PROCEDURE

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.

CTPV

Eligibility Criteria

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

You may qualify if:

• 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;
• Treated with combined variceal embolization and partial splenic artery embolization;
• Availability of at least one postoperative follow-up examination with documented clinical data and survival status.

You may not qualify if:

• Concomitant malignant tumor;
• Active infection

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Portal Vein, Cavernous Transformation Of

Study Officials

• Jun Tie

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Tie, M.D.,Ph.D.

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: December 16, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)