NCT07918378Recruiting
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Patients With Cirrhosis at University Medical Center Ho Chi Minh City
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 167 (estimated)
- First submitted
- 1 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Diseases
- High blood pressure
- NCT number
- NCT07918378
What you commit to
- Study type: Observational
- Planned participants: 167
- From 1 Oct 2026 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Non-cirrhotic portal hypertension, or liver cirrhosis that is unconfirmed or questionable.
- Gastrointestinal bleeding due to etiologies completely unrelated to portal hypertension (e.g., peptic ulcer disease, gastric cancer, Mallory-Weiss tears, vascular ectasias), or bleeding of completely unknown origin.
Other
- Pregnant or lactating women.
- Missing critical medical records or core pre-procedural/outcome data that would prevent the primary outcome assessment
Who the study is looking for
- Patient is aged 18 years or older on the day of admission.
- Confirmed diagnosis of liver cirrhosis by attending clinicians based on clinical findings, laboratory tests, imaging studies (ultrasound, CT, MRI, elastography), or liver histology if available.
- Diagnosis of acute portal hypertension-related gastrointestinal bleeding requiring treatment with at least one endovascular intervention technique (TIPS, PARTO, CARTO, ATO, or combined techniques).
- For patients enrolled in the prospective cohort, signed and dated written informed consent must be obtained prior to study inclusion.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Ho Chi Minh City Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.