Efficacy and Safety of Variceal Embolization Combined With Partial Splenic Artery Embolization fo… (NCT07310316) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Variceal Embolization Combined With Partial Splenic Artery Embolization for Variceal Bleeding in Cavernous Transformation of Portal Vein.
China26 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence of gastroesophageal variceal rebleeding.
Timeframe: 12 months
Trial details
NCT IDNCT07310316
SponsorAir Force Military Medical University, China