Early Diagnosis of Oxaliplatin-induced Portal Hypertension

• Conditions: Received Oxaliplatin-based Chemotherapy; Colorectal Cancer; Gastroesophageal Varices
• Interventions: Diagnostic Test: the level of vWF

• Registration Number: NCT04524650
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, the investigators aim to evaluate the values of potential biomarkers in diagnosing patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-24
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28
• Study Start: 2020-08-31
• Primary Completion: 2021-10-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Male or female patients aged 18-75
• Had a history of oxaliplatin-based chemotherapy for the treatment of colorectal cancer surgery;

Exclusion Criteria

• Combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
• With colorectal cancer required further anti-tumor treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stage 3	the level of vWF	occurrence of portal hypertension and/or gastroesophageal varices
stage 0	the level of vWF	without liver function injury or splenomegaly
stage 1	the level of vWF	occurrence of liver function injury (ALT or AST \> 2 ULN (upper limit of normal)
stage 2	the level of vWF	occurrence of splenomegaly or reduced platelet count (\<150 X10\^9/L)

Primary Outcome Measures

Name	Time	Method
the severity of portal hypertension	1 day (the same time as diagnosis)	High portal pressure

Trial Locations

Locations (1)

Department of Gastroenterology and Hepatology; 🇨🇳 Shanghai, Shanghai, China