Cavernous Transformation of Portal VeinNCT07310316
Efficacy and Safety of Variceal Embolization Combined With Partial Splenic Artery Embolization for Variceal Bleeding in Cavernous Transformation of Portal Vein.
A study testing Variceal Embolization Combined With Partial Splenic Artery Embolization in people with Cavernous Transformation of Portal Vein and Gastroesophageal Varices Bleeding, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cavernous Transformation of Portal Vein, Gastroesophageal Varices Bleeding
- What is being tested?
- Variceal Embolization Combined With Partial Splenic Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Concomitant malignant tumor;
- Active infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Air Force Military Medical University
Xi'an, Shaanxi, 710032
Jun Tie, M.D.,Ph.D., +862984771537, tiejun7776@163.com
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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.
- Being tested
- Variceal Embolization Combined With Partial Splenic Artery Embolization
- Keywords
- Cavernous Transformation of Portal Vein, Esophageal and gastric variceal bleeding, Variceal Embolization, Partial Splenic Artery Embolization
- Medical subject headings
- Portal Vein, Cavernous Transformation Of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variceal Embolization Combined With Partial Splenic Artery EmbolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Variceal Embolization Combined With Partial Splenic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
All-cause rebleeding
Measured: 12 months
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Liver transplantation-free survival
Defined as the time from the TIPS procedure to the end of follow-up, liver transplantation, or death.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavernous Transformation of Portal VeinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tie Jun, Air Force Military Medical University, China
- Investigators
- Jun Tie, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310316
- Sponsor's protocol ID
- KY20252459-F-1
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07310316
- Acronym / sponsor ID
- KY20252459-F-1
- Keywords
- Cavernous Transformation of Portal Vein, Esophageal and gastric variceal bleeding, Variceal Embolization, Partial Splenic Artery Embolization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTPV | Experimental | Procedure: Variceal Embolization Combined With Partial Splenic Artery EmbolizationA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Concomitant malignant tumor;
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variceal Embolization Combined With Partial Splenic Artery EmbolizationVariceal 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. | Procedure or surgery | CTPV |
Primary outcome
Cumulative incidence of gastroesophageal variceal rebleeding.
Time frame: 12 months
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.
5 secondary outcomes
All-cause rebleeding
Time frame: 12 months
New or worsening ascites
Time frame: 12 months
Incidence of overt hepatic encephalopathy
Time frame: 12 months
Liver function
Time frame: 12 months
Liver transplantation-free survival
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Yes
Related trials for Cavernous Transformation of Portal Vein
Active, not recruitingObservational study
Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction
Hypertension, Portal, Interventional Radiology
Not yet recruiting
Mesenteric Vein Access for OPVT-Related Recurrent Variceal Bleeding: An Ambispective Cohort
Occlusive Portal Vein Thrombosis (OPVT), Cavernous Transformation of Portal Vein
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Tie principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variceal Embolization Combined With Partial Splenic Artery Embolization in people with Cavernous Transformation of Portal Vein and Gastroesophageal Varices Bleeding, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Tie, M.D.,Ph.D. (+862984771537, tiejun7776@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of gastroesophageal variceal rebleeding. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.