Gastroesophageal Varices Hemorrhage, Gastrointestinal Cancer, Received Oxaliplatin-based Chemotherapy
Conditions
Keywords
portal hypertension, Gastrointestinal Cancer, oxaliplatin, gastroesophageal variceal bleeding, endoscopic treatment, Transjugular Intrahepatic Portosystemic Shunt
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.
Interventions
PROCEDUREEndoscopic treatment
Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
PROCEDURETIPS
Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Shanghai Minhang Central Hospital
Anhui Provincial Hospital
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-week re-bleeding | 24 weeks | Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 8-week re-bleeding | 8 weeks | Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours |
| 8-week mortality | 8 weeks | death |
| 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 |
| 24-week adverse events | 24 weeks | Other complications of portal hypertension such as the progression of ascites, liver failure, etc. |
Countries
China
Contacts
Primary ContactXiaoquan HUANG, M.D.
Outcome results
None listed