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Oxaliplatin-induced Portal Hypertension

Fudan University logo

Fudan University

Status

Unknown

Conditions

Gastroesophageal Varices Hemorrhage
Received Oxaliplatin-based Chemotherapy
Colorectal Cancer

Treatments

Procedure: Individualized Treatment

Study type

Interventional

Funder types

Other

Identifiers

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

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Individualized Treatment Group
Experimental group
Treatment:
Procedure: Individualized Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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