NCT07918378 Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
| NCT ID | NCT07918378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) |
| Condition | Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 167 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 167 participants in total. It began in 2026-10-01 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant or lactating women. * 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. * Missing critical medical records or core pre-procedural/outcome data that would prevent the primary outcome assessment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07918378 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07918378 currently recruiting?
Yes, NCT07918378 is actively recruiting participants. Contact the research team at thong.vd@umc.edu.vn for enrollment information.
Where is the NCT07918378 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT07918378 clinical trial?
NCT07918378 is sponsored by University Medical Center Ho Chi Minh City (UMC). The trial plans to enroll 167 participants.