Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Fudan University

Status: Unknown

Conditions: Gastroesophageal Varices Hemorrhage; Received Oxaliplatin-based Chemotherapy; Gastrointestinal Cancer

Treatments: Procedure: Endoscopic treatment; Procedure: TIPS

Study type: Interventional

Funder types: Other

Identifiers

NCT05141617

PLAEGV-TRE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Endoscopic treatment group

Experimental group

Description:

Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.

Treatment:

Procedure: Endoscopic treatment

TIPS group

Experimental group

Description:

Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.

Treatment:

Procedure: TIPS