Combining variceal embolization and partial splenic artery embolization for variceal bleeding in cavernous transformation of the 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.
This tests whether adding partial splenic artery embolization to variceal embolization can stop recurrent gastroesophageal variceal bleeding in adults with cavernous transformation of the portal vein who have not responded to medicines and endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07310316 on ClinicalTrials.gov |
What this trial studies
This interventional protocol delivers targeted embolization to bleeding gastroesophageal varices together with partial embolization of the splenic artery in patients with cavernous transformation of the portal vein and extensive portal vein thrombosis. It is intended for patients with portal vein occlusion and inadequate portal inflow who are not candidates for TIPS, and the procedures are performed radiologically. Outcomes of interest include control of recurrent bleeding, procedure-related complications, and short- to mid-term survival and clinical status on follow-up. Data are collected from postoperative examinations and documented clinical follow-up visits.
Who should consider this trial
Good fit: Adults aged 18–75 with imaging-confirmed cavernous transformation of the portal vein and portal vein thrombosis extending into the splenic and superior mesenteric veins who have recurrent variceal bleeding despite pharmacologic and endoscopic treatment and who undergo the combined embolization procedures are ideal candidates.
Not a fit: Patients with concurrent malignant tumors, active infections, or other major comorbidities — and those who are good candidates for TIPS or have preserved portal inflow — may not receive benefit from this specific combined embolization approach.
Why it matters
Potential benefit: If successful, the combined embolization approach could reduce recurrent variceal bleeding and avoid higher-risk surgery or ineffective therapies for patients with portal vein occlusion.
How similar studies have performed: Small case series and interventional reports have shown embolization strategies can control bleeding in similar settings, but combined variceal plus partial splenic artery embolization remains relatively novel and not validated in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Xi'an, Shaanxi
- Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Jun Tie — Air Force Military Medical University, China
- Study coordinator: Jun Tie, M.D.,Ph.D.
- Email: tiejun7776@163.com
- Phone: +862984771537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.