NCT06635122

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

Case-Control Study of Transjugular Intrahepatic Portosystemic Shunt in Treating Platinum-Related Porto-Sinusoidal Vascular Disease With Esophagogastric Variceal Bleeding

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Platinum-based compounds are widely employed in chemotherapy regimens, yet they are associated with a range of adverse effects, most notably Porto-Sinusoidal Vascular Disease (PSVD). PSVD can trigger portal hypertensive complications, including esophagogastric varices and ascites. Platinum-related PSVD constitutes a variant of intrahepatic presinusoidal portal hypertension, manifesting clinical symptoms analogous to those of liver cirrhosis. There is a scarcity of clinical data pertaining to these patients, and therapeutic strategies should be extrapolated from the management of complications associated with cirrhotic portal hypertension. Presently, the combination of non-selective beta-blockers (NSBB) with endoscopic therapies is advocated as the primary therapeutic modality for the secondary prevention of variceal bleeding, with transjugular intrahepatic portosystemic shunt (TIPS) being employed subsequent to the failure of firstline treatments. A study by Shanghai Zhongshan Hospital revealed that patients with gastroesophageal variceal bleeding following oxaliplatin-based chemotherapy required more frequent endoscopic treatments to prevent rebleeding compared to those with cirrhosis, and exhibited higher rates of rebleeding and mortality. This suggests the suboptimal efficacy of endoscopic treatments for secondary prevention in this patient population. Additionally, findings from a retrospective study conducted by our institution demonstrated that PSVD patients treated with TIPS for variceal bleeding achieved rebleeding control comparable to cirrhotic patients with similar liver function. However, PSVD patients experienced a lower incidence of liver-related complications, such as overt hepatic encephalopathy and hepatic insufficiency, along with a reduced mortality rate. Therefore, it is postulated that patients with platinum-related PSVD and esophagogastric varices may experience a lower rebleeding rate following TIPS intervention compared to those receiving endoscopic treatment, without an increased risk of hepatic encephalopathy. TIPS may present a safer treatment option for this cohort, with a reduced incidence 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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-10-31
• Completion: 2025-10-01
• First posted: 2024-10-10
• Last updated: 2024-10-15

Locations

1 site across 1 country: China