Early Diagnosis of Oxaliplatin-induced Portal Hypertension

Fudan University

Status: Unknown

Conditions: Received Oxaliplatin-based Chemotherapy; Gastroesophageal Varices; Colorectal Cancer

Treatments: Diagnostic Test: the level of vWF

Study type: Observational

Funder types: Other

Identifiers

NCT04524650

PLAEGV-DIA

Details and patient eligibility

About

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.

Enrollment: 370 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

370 participants in 4 patient groups

stage 0

Description:

without liver function injury or splenomegaly

Treatment:

Diagnostic Test: the level of vWF

stage 1

Description:

occurrence of liver function injury (ALT or AST \> 2 ULN (upper limit of normal)

Treatment:

Diagnostic Test: the level of vWF

stage 2

Description:

occurrence of splenomegaly or reduced platelet count (\<150 X10\^9/L)

Treatment:

Diagnostic Test: the level of vWF

stage 3

Description:

occurrence of portal hypertension and/or gastroesophageal varices

Treatment:

Diagnostic Test: the level of vWF