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TIPS for Platinum-Related Porto-Sinusoidal Vascular Disease With Variceal Bleeding

NCT06635122 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-10-15

No results posted yet for this study

Summary

Platinum-based compounds are associated with several adverse effects, including Porto-Sinusoidal Vascular Disease (PSVD). Therapeutic strategies for platinum-related PSVD are based on the management of complications seen in cirrhotic portal hypertension. Currently, a combination of non-selective beta-blockers (NSBB) and endoscopic therapies, such as endoscopic band ligation and endoscopic cyanoacrylate injection, is recommended as the primary approach for the secondary prevention of variceal rebleeding, with Transjugular Intrahepatic Portosystemic Shunt (TIPS) reserved for cases in which first-line treatments fail.

However, previous research indicates that endoscopic treatments for the secondary prevention of esophagogastric variceal bleeding show suboptimal efficacy in PSVD patients. In contrast, TIPS has demonstrated comparable rebleeding control but with a lower incidence of liver-related complications and reduced mortality in PSVD patients compared to cirrhotic patients with similar liver function. Based on these findings, the investigators hypothesize that TIPS may be a safer option for this cohort, offering lower rebleeding rates than endoscopic therapy, reduced incidences of hepatic encephalopathy and liver insufficiency, and improved survival rates compared to patients with cirrhosis.

Conditions

  • Porto-Sinusoidal Vascular Disease
  • Cirrhosis Due to Hepatitis B
  • Esophageal Variceal Rebleeding
  • Gastric Variceal Bleeding

Interventions

PROCEDURE

Transjugular intrahepatic portosystemic shunt

Transjugular intrahepatic portosystemic shunt (TIPS) is a procedure that uses imaging guidance to connect the portal vein to the hepatic vein in the liver. The TIPS-dedicated stent (Gore, Arizona, USA)was emplaced within the liver and gradually expanded utilizing a balloon with a diameter ranging from 6 to 10 millimeters, aiming for a decrease in portal-venous pressure gradient to less than 12 mmHg or achieve a reduction of 25 to 50% relative to the baseline pressure.

PROCEDURE

Endoscopic treatment

Endoscopic variceal ligation, endoscopic injection sclerotherapy, endoscopic variceal histoacryl injection therapy , or a combination of several methods were selected according to the location, size, and shape of the patient's varicose veins.Treatment failure can be transferred to TIPS therapy.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Jun Tie, M.D.,Ph.D. · Air Force Military Medical University, China

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-10-31
Completion
2025-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635122 on ClinicalTrials.gov