NCT06122753Not yet recruiting
Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT): A Multicenter Randomized Trial
Source: ClinicalTrials.gov · Last updated 8 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Portal vein thrombosis (PVT) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. Whether patients with acute esophagogastric variceal bleeding with occlusive PVT benefit from preemptive TIPS is still controversial. The present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive PVT treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive TIPS (performed during the first 1-3 days after endoscopic procedure). The primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 3 Nov 2023
- Start date
- Jan 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- West China Hospital
- Diseases
- High blood pressure
- NCT number
- NCT06122753
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Jan 2024 to the primary completion date, Dec 2026
- 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.
Prior treatment
- Prior treatment with TIPS or surgical shunt;
Other illness
- Presence of other systemic malignant tumors with expected survival time not exceeding 6 months;
- Presence of uncontrollable infection or sepsis;
- Presence of cardiac, pulmonary, or renal failure;
Other
- Presence of contraindications to endoscopic treatment, carvedilol, or TIPS;
- Presence of hepatocellular carcinoma exceeding Milan criteria;
- Pregnant or lactating women;
- Refusal to sign the informed consent form.
Who the study is looking for
- Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
- Admission due to acute bleeding from esophagogastric varices;
- Thrombus in the main trunk of the portal vein occupying ≥50% of the lumen.
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.