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The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8mm-TIPS | Active Comparator | Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. |
|
| EVL plus propranolol | Active Comparator | Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8mm-TIPS | Procedure |
| ||
| Endoscopic variceal ligation |
| Measure | Description | Time Frame |
|---|---|---|
| Variceal rebleeding rate | Analysis | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic encephalopathy rate | Analysis | 3 years |
| Number of participants with improving or worsening hepatic function | Analysis | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37606572 | Derived | Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201. | |
| 33089892 | Derived |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
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|
| Propranolol | Drug |
|
| 8mm ePTFE-covered stent | Device |
|
| TIPS dysfunction rate | Analysis | 3 years |
| The incidence of complications | Analysis | 3 years |
| Number of participants with improving or worsening quality of life | Analysis | 3 years |
| Mortality rate | Analysis | 3 years |
| Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3. |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |