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

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.

NCT Number	NCT06635122
Lead Sponsor	Air Force Military Medical University, China Collaborators: Shanghai Zhongshan Hospital
Conditions	Porto-Sinusoidal Vascular Disease, Cirrhosis Due to Hepatitis B, Esophageal Variceal Rebleeding, Gastric Variceal Bleeding
Enrollment	150 participants
Start Date	2024-07-01
Primary Completion	2024-10-31 (estimated)
Study Completion	2025-10-01 (estimated)
Updated on ClinicalTrials.gov	2024-10-15