An observational study in Cirrhosis, Portal Hypertension Related to Cirrhosis and GI Bleeding, sponsored by University Medical Center Ho Chi Minh City (UMC). Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University Medical Center Ho Chi Minh City (UMC) · Observational
BACKGROUND. Portal hypertension-related gastrointestinal bleeding (GIB), especially gastric variceal bleeding, is a critical complication of liver cirrhosis that is associated with high rebleeding and mortality rates. While endovascular interventions such as transjugular intrahepatic portosystemic shunt (TIPS) and retrograde/antegrade transvenous obliteration (RTO/ATO) represent major advances, real-world clinical data and localized prognostic models for patients undergoing these treatments are extremely sparse in Vietnam.
OBJECTIVE. This study aims to describe the clinical and laboratory characteristics, evaluate technical and clinical treatment outcomes, and identify independent pre-procedural prognostic factors associated with adverse clinical outcomes after endovascular interventions.
METHODS. A hybrid cohort study combining a retrospective phase (January 2021 - September 2026, target n=117) and a prospective phase (October 2026 - March 2028, target n=50) will be conducted at the University Medical Center Ho Chi Minh City. The total sample size of 167 patients is powered using Cochran's single proportion formula and the rule of 10 events per variable (EPV) for logistic regression modeling. Demographics, lab markers, hepatic scoring systems (Child-Pugh, MELD, MELD-Na, MELD 3.0,...), procedural parameters, and clinical outcomes (initial bleeding control, rebleeding, in-hospital and 6-week mortality) will be recorded. Univariate and multivariate logistic and Cox proportional hazard regression will be used to analyze predictors of outcomes.
IMPACT. The TOPIC study will establish the first systematic real-world clinical database of endovascular portal hypertension interventions in Vietnam. Defining localized prognostic variables will support risk stratification, optimize patient selection, lower healthcare costs, and establish practical guidelines for personalized clinical management.
Portal hypertension-related gastrointestinal bleeding is a major clinical problem in patients with cirrhosis and may require endovascular treatment when bleeding is severe, recurrent, refractory to conventional therapy, or associated with complex portosystemic vascular anatomy. Endovascular management includes decompressive procedures such as transjugular intrahepatic portosystemic shunt (TIPS) and obliteration techniques such as coil-assisted or plug-assisted retrograde transvenous obliteration (CARTO/PARTO) and antegrade transvenous obliteration (ATO). The choice of procedure is influenced by the bleeding presentation, variceal anatomy, portosystemic collateral pathways, portal vein patency, hepatic function, and the clinical condition of the patient.
The clinical course following these interventions may vary substantially according to baseline liver function, severity of the acute bleeding episode, vascular anatomy, and the type of intervention performed. Important outcomes include achievement of initial bleeding control, recurrent bleeding, procedure-related complications, hepatic encephalopathy, worsening ascites, need for reintervention, and mortality. However, the relationship between pre-procedural characteristics and these outcomes has not been systematically evaluated in a broad Vietnamese cohort undergoing different endovascular techniques.
The TOPIC study is a hybrid observational cohort conducted at the Department of Gastroenterology and the Endovascular Intervention Unit of the University Medical Center Ho Chi Minh City. The study includes two components: a retrospective cohort of eligible patients treated from January 2021 through September 2026 and a prospective cohort of patients consecutively enrolled from October 2026 through March 2028. The study population consists of adults with confirmed cirrhosis who present with acute gastrointestinal bleeding attributable to portal hypertension and undergo at least one endovascular intervention, including TIPS, PARTO, CARTO, ATO, or combined procedures. Pregnant or lactating women, patients without confirmed cirrhosis, patients with bleeding unrelated to portal hypertension, and patients with insufficient medical records for assessment of the primary outcome will be excluded.
For retrospectively identified participants, clinical information will be obtained from electronic medical records, imaging and PACS systems, endoscopy records, and digital subtraction angiography databases. For prospectively enrolled participants, information will be collected using standardized case report forms during hospitalization, with follow-up at six weeks after discharge through clinical assessment or structured telephone contact. Baseline information will include demographic characteristics, cirrhosis etiology, history of portal hypertensive bleeding or hepatic encephalopathy, ascites, characteristics of the bleeding episode, endoscopic findings, cross-sectional imaging findings, portal and systemic venous anatomy, and the presence of portal vein thrombosis.
Laboratory and disease-severity variables will be obtained using the most recent measurements available before the endovascular procedure. These include hemoglobin, platelet count, INR, albumin, total bilirubin, creatinine, serum sodium, aminotransferases, inflammatory markers, and, when available, ammonia and NT-proBNP. Several established liver disease severity scores will be calculated, including Child-Pugh, MELD, MELD-Na, MELD 3.0, and CLIF-C AD. The study will specifically examine whether these pre-procedural measures provide clinically useful information for identifying patients at higher risk of adverse outcomes.
Procedural characteristics will include the endovascular technique, urgency of intervention, vascular access route, embolic materials, TIPS stent diameter when applicable, portal venous pressure measurements, and portosystemic pressure gradient measurements when available. Technical success will be assessed according to the procedure performed. For TIPS, this requires establishment of a functioning shunt, whereas for embolization procedures it requires complete or near-complete occlusion of the targeted varices or shunt on final angiography.
Clinical outcomes will be assessed after the intervention. Initial bleeding control is defined by absence of ongoing bleeding, hemodynamic stabilization, and no requirement for repeat intervention or endoscopy during the first 72 hours. Rebleeding will be identified on the basis of recurrent clinical bleeding, acute anemia, endoscopic or laboratory evidence, transfusion requirements, or repeat intervention. Other outcomes include in-hospital mortality, clinical success, post-intervention hepatic encephalopathy, worsening ascites, worsening esophageal varices, post-procedural complications, reintervention, length of hospital stay, and six-week post-discharge mortality in the prospective cohort.
The principal prognostic analysis will evaluate associations between pre-procedural characteristics and adverse clinical outcomes. Candidate predictors will include demographic characteristics, clinical presentation, laboratory parameters, liver disease severity scores, vascular anatomy, and characteristics of the planned intervention. Logistic regression will be used for binary outcomes, while Cox proportional hazards models will be applied to time-to-event outcomes. Kaplan-Meier methods will be used to describe event-free survival and mortality over time. The discriminative performance of Child-Pugh, MELD, MELD-Na, MELD 3.0, and CLIF-C AD will also be compared using receiver operating characteristic analysis and the area under the curve.
The study is designed to provide a structured clinical dataset covering different endovascular approaches within a single tertiary-care center. By examining both procedural results and patient-level factors present before intervention, the study will characterize heterogeneity in clinical outcomes and explore variables that may assist future risk stratification and selection of endovascular treatment strategies in patients with cirrhosis and portal hypertension-related gastrointestinal bleeding.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 167 is close to the median of 157 across 386 observational studies indexed under Fibrosis.
Browse Fibrosis studies →University Medical Center Ho Chi Minh City (UMC) is the lead sponsor of 34 studies on the registry; 19 are open to participants now.
Compared within Fibrosis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Adult patients with confirmed liver cirrhosis who present with acute portal hypertension-related gastrointestinal bleeding and undergo at least one endovascular intervention, including transjugular intrahepatic portosystemic shunt (TIPS), plug-assisted retrograde transvenous obliteration (PARTO), coil-assisted retrograde transvenous obliteration (CARTO), antegrade transvenous obliteration (ATO), or combined endovascular techniques. Patients are identified from the Department of Gastroenterology and Endovascular Intervention Unit at University Medical Center Ho Chi Minh City. The study includes retrospectively identified patients treated from January 2021 to September 2026 and prospectively enrolled patients from October 2026 to March 2028.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with confirmed liver cirrhosis who present with portal hypertension-related gastrointestinal bleeding and undergo at least one endovascular intervention, including TIPS, PARTO, CARTO, ATO, or combined techniques. Clinical characteristics, liver disease severity, vascular anatomy, procedural parameters, treatment outcomes, complications, rebleeding, and mortality will be evaluated.
Procedure: Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding
Endovascular treatment of portal hypertension-related gastrointestinal bleeding in patients with cirrhosis. Procedures include transjugular intrahepatic portosystemic shunt (TIPS), plug-assisted retrograde transvenous obliteration (PARTO), coil-assisted retrograde transvenous obliteration (CARTO), antegrade transvenous obliteration (ATO), or combined endovascular techniques. The specific procedure is selected according to the patient's clinical condition and portosystemic vascular anatomy. Procedural characteristics and technical success are recorded, and post-procedural clinical outcomes, complications, rebleeding, and mortality are evaluated.
Number of Participants With a Composite Adverse Clinical Outcome After Endovascular Intervention
A composite adverse clinical outcome is defined as the occurrence of at least one of the following events after endovascular intervention: (1) gastrointestinal rebleeding after initial bleeding control, (2) in-hospital mortality during the hospitalization in which the endovascular intervention was performed, or (3) death from any cause within 6 weeks after hospital discharge in the prospective cohort. The outcome will be reported as the number and percentage of participants experiencing at least one component of the composite outcome.
Time frame: From endovascular intervention through hospital discharge for rebleeding and in-hospital mortality; 6 weeks after discharge for mortality in the prospective cohort.
Number of Participants With Technical Success of Endovascular Intervention
Technical success is defined as successful completion of the planned endovascular intervention. For TIPS, technical success requires successful creation of the portosystemic shunt with flow through the stent. For transvenous obliteration or embolization procedures, technical success requires complete or near-complete occlusion of the target varices or shunt on final digital subtraction angiography (DSA). The outcome will be reported as the number and percentage of participants achieving technical success.
Time frame: Periprocedural, from initiation to completion of the endovascular intervention.
Number of Participants With Initial Bleeding Control After Endovascular Intervention
Initial bleeding control is defined as no ongoing gastrointestinal bleeding after endovascular intervention, stable hemodynamics, and no need for repeat endovascular intervention or endoscopy within the first 72 hours after the procedure. The outcome will be reported as the number and percentage of participants achieving initial bleeding control
Time frame: Within 72 hours after endovascular intervention
Number of Participants With Gastrointestinal Rebleeding After Endovascular Intervention
Gastrointestinal rebleeding is defined as recurrent hematemesis, melena, or acute anemia after initial bleeding control, with clinical, endoscopic, or laboratory evidence of recurrent bleeding, or requiring blood transfusion or reintervention. The outcome will be reported as the number and percentage of participants experiencing gastrointestinal rebleeding.
Time frame: From 72 hours after endovascular intervention through 6 weeks after hospital discharge
Number of Participants Who Died During the Hospitalization After Endovascular Intervention
In-hospital mortality is defined as death from any cause during the same hospitalization in which the endovascular intervention was performed. The outcome will be reported as the number and percentage of participants who died during hospitalization.
Time frame: From the date of endovascular intervention until hospital discharge or death, whichever occurs first, assessed up to 18 months
Number of Participants Who Died Within 6 Weeks After Hospital Discharge
Six-week post-discharge mortality is defined as death from any cause occurring within 6 weeks after hospital discharge following endovascular intervention. The outcome will be reported as the number and percentage of participants who died during the 6-week post-discharge follow-up period.
Time frame: From hospital discharge through 6 weeks after discharge
Number of Participants With Clinical Success After Endovascular Intervention
Clinical success is defined as technical success accompanied by initial bleeding control and no bleeding-related death during the early post-intervention period. The outcome will be reported as the number and percentage of participants achieving clinical success.
Time frame: Within 72 hours after endovascular intervention.
Number of Participants Requiring Reintervention After Endovascular Intervention
Reintervention is defined as the need for repeat endoscopy, repeat endovascular intervention, or surgery because of gastrointestinal rebleeding, residual varices, or post-intervention complications. The outcome will be reported as the number and percentage of participants requiring reintervention.s
Time frame: From the end of the initial endovascular intervention through 6 weeks after hospital discharge
Duration of Hospitalization After Endovascular Intervention
Length of hospital stay is defined as the duration of hospitalization, measured in days, from the date of hospital admission to the date of hospital discharge. The outcome will be reported as the number of days of hospitalization.
Time frame: From the date of hospital admission until hospital discharge, assessed up to 18 months.
Number of Participants With New-Onset or Worsening Hepatic Encephalopathy After Endovascular Intervention
Post-intervention hepatic encephalopathy is defined as new-onset or worsening hepatic encephalopathy after endovascular intervention, as documented in the medical record. The outcome will be reported as the number and percentage of participants who develop new-onset or worsening hepatic encephalopathy.
Time frame: From the end of the endovascular intervention through 6 weeks after hospital discharge
Number of Participants With New-Onset or Worsening Ascites After Endovascular Intervention
Worsening ascites is defined as new-onset ascites or increased severity of ascites after endovascular intervention. The outcome will be reported as the number and percentage of participants who develop new-onset or worsening ascites.
Time frame: From the date of endovascular intervention until hospital discharge, assessed up to 18 months.
Number of Participants With Post-Intervention Complications After Endovascular Intervention
Post-intervention complications are defined as complications occurring after the endovascular intervention during hospitalization or follow-up, including fever, infection, liver failure, renal failure, embolic material migration, thrombosis, or access-site complications. The outcome will be reported as the number and percentage of participants experiencing at least one post-intervention complication.
Time frame: From the end of the endovascular intervention through 6 weeks after hospital discharge.
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University Medical Center Ho Chi Minh City (UMC)