Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Not Applicable

• Conditions: Gastroesophageal Varices Hemorrhage; Gastrointestinal Cancer; Received Oxaliplatin-based Chemotherapy
• Interventions: Procedure: TIPS; Procedure: Endoscopic treatment

• Registration Number: NCT05141617
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-01
• Study Start: 2021-11-03
• Study First Submitted QC: 2021-11-20
• Last Update Submitted: 2021-11-20
• Study First Posted: 2021-12-02
• Last Update Posted: 2021-12-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS group	TIPS	Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.
Endoscopic treatment group	Endoscopic treatment	Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.

Primary Outcome Measures

Name	Time	Method
24-week re-bleeding	24 weeks	Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gastroenterology and Hepatology; 🇨🇳 Shanghai, Shanghai, China