Oxaliplatin-induced Portal Hypertension

Not Applicable

• Conditions: Gastroesophageal Varices Hemorrhage; Received Oxaliplatin-based Chemotherapy; Colorectal Cancer
• Interventions: Procedure: Individualized Treatment

• Registration Number: NCT04524676
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-24
• Last Update Posted: 2020-08-24
• Study Start: 2020-08-31
• Primary Completion: 2021-10-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individualized Treatment Group	Individualized Treatment	-

Primary Outcome Measures

Name	Time	Method
1-year rebleeding rate	1 year	1-year rebleeding rate

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Gastroenterology and Hepatology; 🇨🇳 Shanghai, Shanghai, China