Early Diagnosis of Oxaliplatin-induced Portal Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Construction and Evaluation of the Early Identification for Oxaliplatin Induced Portal Hypertension

Conditions
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Gastroesophageal Varices, Colorectal Cancer, Received Oxaliplatin-based Chemotherapy

Intervention / Treatment
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* Diagnostic Test: the level of vWF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stage 0<br>without liver function injury or splenomegaly | Diagnostic Test: the level of vWF<br>* the peripheral level of vWF<br>|
| stage 1<br>occurrence of liver function injury (ALT or AST > 2 ULN (upper limit of normal) | Diagnostic Test: the level of vWF<br>* the peripheral level of vWF<br>|
| stage 2<br>occurrence of splenomegaly or reduced platelet count (<150 X10^9/L) | Diagnostic Test: the level of vWF<br>* the peripheral level of vWF<br>|
| stage 3<br>occurrence of portal hypertension and/or gastroesophageal varices | Diagnostic Test: the level of vWF<br>* the peripheral level of vWF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the severity of portal hypertension | High portal pressure | 1 day (the same time as diagnosis) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portal hypertension, splenomegaly, colorectal carcinoma, oxaliplatin, hepatotoxicity