Oxaliplatin-induced Portal Hypertension

August 20, 2020 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Department of gastroenterology and hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year rebleeding rate
Time Frame: 1 year
1-year rebleeding rate
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year death rate
Time Frame: 1 year
1-year death rate
1 year
Complications of portal hypertension
Time Frame: 1 year
The occurrence of complications of portal hypertension including ascites, liver failure, et al.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 31, 2020

Primary Completion (ANTICIPATED)

October 31, 2021

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (ACTUAL)

August 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAEGV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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