Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Shanghai Zhongshan Hospital
Updated on 9 December 2021
endoscopy
oxaliplatin

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.

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.

Details
Condition Gastrointestinal Neoplasm, gastrointestinal cancer, Gastroesophageal Varices Hemorrhage, gastrointestinal cancers, Digestive System Neoplasms, Neoplasm of unspecified nature of digestive system, GASTROINTESTINAL DISORDER, Gastrointestinal Diseases and Disorders, Received Oxaliplatin-based Chemotherapy
Treatment TIPS, Endoscopic treatment
Clinical Study IdentifierNCT05141617
SponsorShanghai Zhongshan Hospital
Last Modified on9 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Having received oxaliplatin-based chemotherapy for at least one cycle
History of variceal bleeding (including hematemesis or melena)
Portal hypertension confirmed by CT or MRI
Esophageal and / or gastric varices confirmed by endoscopy
Informed consent signed

Exclusion Criteria

With serious life-threatening diseases of circulation / blood / respiratory system
With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.)
With contraindications of endoscopic treatments and TIPS
Participation refused
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