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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 in patients with Child A cirrhosis
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 | Device | Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variceal rebleeding rate | Analysis | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic encephalopathy rate | Analysis | 3 years |
| TIPS dysfunction rate | Analysis | 3 years |
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Inclusion Criteria:
Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -
Exclusion Criteria:
The presence of gastric varices Non-cirrhotic portal hypertension Portal vein thrombosis The history of hepatic encephalopathy Total bilirubin ≥51.3 umol/L Previous treatment of TIPS or surgery Proven malignancy including hepatocellular carcinoma Contraindications to TIPS、EVL or propranolol End-stage renal disease under renal replacement therapy; Cardiorespiratory failure Pregnancy or patients not giving informed consent for endoscopic procedure
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West china hospital | Recruiting | Chengdu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33089892 | Derived | 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. |
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| endoscopic variceal ligation (EVL) | Procedure | Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. |
|
| Propranolol | Drug | Appropriate dose of propranolol was administered to the patients. |
|
| The incidence of complications | Analysis | 3 years |
| Mortality rate | Analysis | 3 years |
| 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 |
| 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 |
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