Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Received Oxaliplatin-based Chemotherapy, Gastroesophageal Varices Hemorrhage, Gastrointestinal Cancer

Intervention / Treatment
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* Procedure: Endoscopic treatment
* Procedure: TIPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having received oxaliplatin-based chemotherapy for at least one cycle History of variceal bleeding (including hematemesis or melena) Portal hypertension confirmed by CT or MRI Esophageal and / or gastric varices confirmed by endoscopy Informed consent signed Exclusion Criteria: With serious life-threatening diseases of circulation / blood / respiratory system With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.) With contraindications of endoscopic treatments and TIPS; Participation refused

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portal hypertension, Gastrointestinal Cancer, oxaliplatin, gastroesophageal variceal bleeding, endoscopic treatment, Transjugular Intrahepatic Portosystemic Shunt