Oxaliplatin-induced Portal Hypertension

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04524676

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Varices Hemorrhage Colorectal Cancer Received Oxaliplatin-based Chemotherapy	Procedure: Individualized Treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 31, 2020

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Individualized Treatment Group	Procedure: Individualized 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.

Arm

Intervention/Treatment

Experimental: Individualized Treatment Group

Procedure: Individualized 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.

Outcome Measures

Primary Outcome Measures

1-year rebleeding rate [1 year]
1-year rebleeding rate

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.