Oxaliplatin-induced Portal Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-09-30

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.

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Detailed Description

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Conditions

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Gastroesophageal Varices Hemorrhage Colorectal Cancer Received Oxaliplatin-based Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized Treatment Group

Group Type EXPERIMENTAL

Individualized Treatment

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No