Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
NCT07918378, Recruiting, University Medical Center Ho Chi Minh City (UMC)
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis | ClinicalTrials.gov |
| NCT number | NCT07918378 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 167 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Medical Center Ho Chi Minh City (UMC) | ClinicalTrials.gov |
| Conditions | Cirrhosis, Portal Hypertension Related to Cirrhosis, GI Bleeding, Gastrointestinal Bleeding | ClinicalTrials.gov |
| Interventions | Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With a Composite Adverse Clinical Outcome After Endovascular Intervention | From endovascular intervention through hospital discharge for rebleeding and in-hospital mortality; 6 weeks after discharge for mortality in the prospective cohort. | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants With Technical Success of Endovascular Intervention | Periprocedural, from initiation to completion of the 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. | ClinicalTrials.gov |
| Secondary | Number of Participants With Initial Bleeding Control After Endovascular Intervention | Within 72 hours 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 | ClinicalTrials.gov |
| Secondary | Number of Participants With Gastrointestinal Rebleeding After Endovascular Intervention | From 72 hours after endovascular intervention through 6 weeks after hospital discharge | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants Who Died During the Hospitalization After Endovascular Intervention | From the date of endovascular intervention until hospital discharge or death, whichever occurs first, assessed up to 18 months | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants Who Died Within 6 Weeks After Hospital Discharge | From hospital discharge through 6 weeks after 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. | ClinicalTrials.gov |
| Secondary | Number of Participants With Clinical Success After Endovascular Intervention | Within 72 hours 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. | ClinicalTrials.gov |
| Other | Number of Participants Requiring Reintervention After Endovascular Intervention | From the end of the initial endovascular intervention through 6 weeks after hospital discharge | 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 | ClinicalTrials.gov |
| Other | Duration of Hospitalization After Endovascular Intervention | From the date of hospital admission until hospital discharge, assessed up to 18 months. | 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. | ClinicalTrials.gov |
| Other | Number of Participants With New-Onset or Worsening Hepatic Encephalopathy After Endovascular Intervention | From the end of the endovascular intervention through 6 weeks after hospital discharge | 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. | ClinicalTrials.gov |
| Other | Number of Participants With New-Onset or Worsening Ascites After Endovascular Intervention | From the date of endovascular intervention until hospital discharge, assessed up to 18 months. | 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. | ClinicalTrials.gov |
| Other | Number of Participants With Post-Intervention Complications After Endovascular Intervention | From the end of the endovascular intervention through 6 weeks after hospital discharge. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)