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Search / Trial NCT06122753

Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis

Launched by WEST CHINA HOSPITAL · Nov 3, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment option for patients with liver disease who have experienced bleeding from swollen veins in the esophagus or stomach, a condition known as variceal bleeding. Specifically, the trial is looking at whether a procedure called preemptive TIPS (a type of shunt that helps reduce pressure in the portal vein) can help these patients who also have a blockage in their portal vein (known as portal vein thrombosis). The aim is to find out if patients treated with both standard care and preemptive TIPS are less likely to experience rebleeding within six weeks compared to those who only receive standard care.

To be eligible for this study, participants must have cirrhosis (a serious liver condition), have been admitted due to acute variceal bleeding, and have a significant blockage in their portal vein. However, individuals who have already had certain treatments, have specific other health issues, or are pregnant cannot participate. If enrolled in the trial, participants will receive either standard treatment or standard treatment along with the preemptive TIPS procedure, and they will be monitored closely to see how well they respond to the different approaches. This research could help improve care for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • Prior treatment with TIPS or surgical shunt;
  • Presence of contraindications to endoscopic treatment, carvedilol, or TIPS;
  • Presence of hepatocellular carcinoma exceeding Milan criteria;
  • 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;
  • Pregnant or lactating women;
  • Refusal to sign the informed consent form.

About West China Hospital

West China Hospital, affiliated with Sichuan University, is a leading medical institution renowned for its comprehensive healthcare services, advanced research initiatives, and commitment to medical education. As a prominent clinical trial sponsor, the hospital leverages its extensive resources and expertise to facilitate innovative research in various therapeutic areas. With a focus on improving patient outcomes and advancing medical knowledge, West China Hospital collaborates with various stakeholders to conduct rigorous clinical trials that adhere to the highest ethical and scientific standards. Its state-of-the-art facilities and multidisciplinary teams ensure the successful execution of trials, contributing significantly to the global healthcare landscape.

Locations

Chengdu, Sichuan, China

Patients applied

0 patients applied

Trial Officials

Xuefeng Luo, Ph.D.

Principal Investigator

West China Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported