NCT05141617

Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Detailed description

Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Conditions

• Gastroesophageal Varices Hemorrhage
• Gastrointestinal Cancer
• Received Oxaliplatin-based Chemotherapy

Interventions

Type	Name	Description
PROCEDURE	Endoscopic treatment	Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
PROCEDURE	TIPS	Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

Timeline

• Start date: 2021-11-03
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-12-02
• Last updated: 2021-12-02

Locations

1 site across 1 country: China