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, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.

Official Title
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Construction and Evaluation of the Early Identification and Individualized Treatment for Oxaliplatin-induced Portal Hypertension

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

Intervention / Treatment
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* Procedure: Individualized Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign written informed consent Male or female patients aged 18-75 diagnosed as portal hypertension by contrast-enhanced computed tomography and confirmed gastroesophageal varices by upper digestive endoscopy; had a history of oxaliplatin-based chemotherapy after 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 Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Treatment Group<br> | Procedure: Individualized Treatment<br>* Patients under evaluation including hepatic venous pressure gradient (HVPG) and contrast-enhanced computed tomography of portal venous. For those patients with a HVPG ≥12mmHg or with extraluminal para-gastric vein will under transjugular intrahepatic portosystemic shunt and others receive endoscopic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year rebleeding rate | 1-year rebleeding rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year death rate | 1-year death rate | 1 year | 
| Complications of portal hypertension | The occurrence of complications of portal hypertension including ascites, liver failure, et al. | 1 year | 

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