Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

November 20, 2021 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial

In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of gastroenterology and hepatology
        • Sub-Investigator:
          • Xiaoquan HUANG
        • Sub-Investigator:
          • Liyuan NI

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:

  1. Having received oxaliplatin-based chemotherapy for at least one cycle
  2. History of variceal bleeding (including hematemesis or melena)
  3. Portal hypertension confirmed by CT or MRI
  4. Esophageal and / or gastric varices confirmed by endoscopy
  5. Informed consent signed

Exclusion Criteria:

  1. With serious life-threatening diseases of circulation / blood / respiratory system
  2. With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.)
  3. With contraindications of endoscopic treatments and TIPS;
  4. Participation refused

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic treatment group
Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.
Procedure: Endoscopic treatment
Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
Experimental: TIPS group
Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.
Procedure: TIPS
Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-week re-bleeding
Time Frame: 24 weeks
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
8-week re-bleeding
Time Frame: 8 weeks
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
8 weeks
8-week mortality
Time Frame: 8 weeks
death
8 weeks
8-week adverse events
Time Frame: 8 weeks
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
8 weeks
24-week mortality
Time Frame: 24 weeks
death
24 weeks
24-week adverse events
Time Frame: 24 weeks
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
24 weeks

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Collaborators

First Affiliated Hospital of Wenzhou Medical University
Anhui Provincial Hospital
Shanghai Minhang Central Hospital

Investigators

  • Principal Investigator: Shiyao CHENCHEN, M.D. & Ph.D, Fudan University

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 (Actual)

November 3, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 20, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 20, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAEGV-TRE

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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