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Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal hypertension.
From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| covered stent | Experimental | Procedure/Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm covered stents (Bard, Fluency). Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No. |
|
| bare stent | Other | Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm bare stents (EV3, protégé; Cordis, Smart). Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| covered stent | Device | A broad range of implant diameters and lengths for the treatment of in-stent restenotic peripheral and central lesions* in patients with AV grafts and AV fistulae Small incremental stent graft lengths to help maintain venous real estate and cannulation area Minimal shortening and radiopaque markers aid in excellent placement accuracy |
| Measure | Description | Time Frame |
|---|---|---|
| restenosis/occlusion rate | The cumulative restenosis rate in 1, 2, 3, 4, or 5-year | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence rate of gastrointestinal bleeding | up to 5 years | |
| recurrence rate of refractory hydrothorax/ascites | the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianli Xu, MD, PhD | Beijing Shijitan Hospital, Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital | Beijing | Beijing Municipality | 100038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30079331 | Derived | Li HB, Yue ZD, Zhao HW, Wang L, Fan ZH, He FL, Dong XQ, Liu FQ. Pathological Features of Mitochondrial Ultrastructure Predict Susceptibility to Post-TIPS Hepatic Encephalopathy. Can J Gastroenterol Hepatol. 2018 Jul 16;2018:4671590. doi: 10.1155/2018/4671590. eCollection 2018. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
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|
| bare stent | Device | A one piece laser cut, self-expanding nitinol stent combining a micromesh design with a multi segmental construction. The 36 strut, 6 bridge construction of the Stent provides an unmatched balance of radial force, scaffolding, and longitudinal stability. The design offers crush recoverable flexibility in the most challenging vasculature, with optimal wall apposition, conformability and minimal foreshortening. It offers a broad portfolio of sizes for the treatment of routine and challenging Iliofemoral lesions. |
|
| up to 5 years |
| survival rate | The 1, 2, 3, 4 and 5-year survival rate | up to 5 years |
| rate of secondary interventional therapy | rate of secondary interventional therapy | up to 5 years |
| incidence rate of hepatic encephalopathy | The incidence rate of hepatic encephalopathy | up to 5 years |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |