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This multicenter RCT is designed to investigate if TIPS with covered stents improves transplant-free survival for cirrhotic patients with early stage of refractory ascites compared to LVP+albumin during 1 year follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPS with PTFE | Experimental | Transjugular Intrahepatic portosystemic shunt with PTFE covered stents |
|
| paracentesis | Active Comparator | Paracentesis with albumine invision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPS | Procedure | Transjugular intrahepatic portosystemic shunt with covered PTFE |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant-free survival | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of paracentesis | 12 months | |
| Frequency of overt Hepatic Encephalopathy | Number of episodes of West Haven grade 2 or greater without precipitating factor | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guohong Han, MD&PhD | Contact | 86-13991969930 | 13991969930@126.com | |
| Hui Chen, MD&PhD | Contact | 86-18710930922 | qychenhui@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guohong Han, PhD&MD | Xi'an International Medical Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, Air Force Medical University | Completed | Xi'an | Shaanxi | 710032 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27663604 | Background | Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Peron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20. | |
| 24627607 |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| D019152 | Paracentesis |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
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| paracentesis |
| Procedure |
paracentasis plus albumine invision |
|
| Nutritional status | 12 months |
| Quality of life | 12 months |
| Other Liver Disease Complications (Adverse Events) | 12 months |
| Xi'an International Medical Center Hospital |
| Recruiting |
| Xi'an |
| Shaanxi |
| 710032 |
| China |
|
| Bai M, Qi XS, Yang ZP, Yang M, Fan DM, Han GH. TIPS improves liver transplantation-free survival in cirrhotic patients with refractory ascites: an updated meta-analysis. World J Gastroenterol. 2014 Mar 14;20(10):2704-14. doi: 10.3748/wjg.v20.i10.2704. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004322 | Drainage |
| D013812 | Therapeutics |
| D011677 | Punctures |
| D008919 | Investigative Techniques |