Colorectal Cancer, Gastroesophageal Varices Hemorrhage, Received Oxaliplatin-based Chemotherapy
Conditions
Keywords
portal hypertension, gastroesophageal variceal bleeding, colorectal carcinoma, splenomegaly, oxaliplatin
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, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.
Interventions
PROCEDUREIndividualized Treatment
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year rebleeding rate | 1 year | 1-year rebleeding rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year death rate | 1 year | 1-year death rate |
| Complications of portal hypertension | 1 year | The occurrence of complications of portal hypertension including ascites, liver failure, et al. |
Countries
China
Outcome results
None listed