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| Name | Class |
|---|---|
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Shanghai Minhang Central Hospital | OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic treatment group | Experimental | Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices. |
|
| TIPS group | Experimental | Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic treatment | Procedure | Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-week re-bleeding | Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoquan HUANG, M.D. | Contact | 008618801733835 | huang.xiaoquan@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shiyao CHENCHEN, M.D. & Ph.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32380558 | Result | Huang X, Li F, Wang L, Xiao M, Ni L, Jiang S, Ji Y, Zhang C, Zhang W, Wang J, Chen S. Endoscopic treatment of gastroesophageal variceal bleeding after oxaliplatin-based chemotherapy in patients with colorectal cancer. Endoscopy. 2020 Sep;52(9):727-735. doi: 10.1055/a-1157-8611. Epub 2020 May 7. |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
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| TIPS | Procedure | Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt |
|
| 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 |
| D005767 |
| Gastrointestinal Diseases |
| D008107 | Liver Diseases |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |