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Portal hypertension is the most common complication in patients with end-stage liver cirrhosis. Portal hypertension-related complications, such as variceal bleeding, often lead to a poor prognosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter.
In theory, a shunt with a larger diameter can result in better stent patency, but it can also lead to reduced liver function and a higher incidence of hepatic encephalopathy (HE) after the TIPS procedure. Therefore, the choice of covered stent diameter needs to consider the factors of shunt efficacy and postoperative liver function. At present, the diameters of TIPS-dedicated stents are typically either 8 or 10 mm. Whether stents with these two diameters can meet all the requirements of TIPS procedures is currently unknown. Different races, cirrhosis etiologies, and liver volumes may require different TIPS diameters. For example, in China, most cases of liver cirrhosis are caused by hepatitis B, resulting in the patient having a smaller liver volume. Therefore, in most Chinese studies, the diameters of TIPS stents are mainly 8 mm. Previous studies have shown that TIPS with an 8-mm covered stent has a shunt effect similar to that of a 10-mm covered stent; however, the incidence of postoperative HE is significantly reduced with an 8-mm stent (27% vs. 43%)14. Nevertheless, an 8-mm covered TIPS still has a high incidence of HE.
The residual liver volume is small for patients with severe atrophic cirrhosis of the liver, and whether this necessitates a covered TIPS with a smaller diameter requires further study. However, there is still no dedicated TIPS stent that is <8 mm in diameter. In this study, we propose an innovative strategy for the creation of a 6-mm shunt to determine if it can achieve a shunt effect similar to that of an 8-mm covered TIPS and reduce the incidence of HE in patients with severe atrophic liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6-mm shunt TIPS group | Experimental | The diameter of TIPS covered stent is 6mm. |
|
| 8-mm shunt TIPS | Active Comparator | The diameter of TIPS covered stent is 8mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| During TIPS operation, shunt diameter or diameter of covered stent | Device | Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter. Due to the lack of a dedicated 6-mm covered stent, we first released a 6-mm diameter stent (SD Express; Boston Scientific Co., or Luminexx; Bard Medical Division) in the liver parenchymal segment of the shunt, and then released an 8-mm TIPS stent (Viatorr; WL Gore &amp; Associates) to create a final 6-mm shunt. |
| Measure | Description | Time Frame |
|---|---|---|
| The 1- year rates of rebleeding | From receiving TIPS to one year after the end of treatment | |
| The 2- year rates of rebleeding | From receiving TIPS to two year after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The 1- year stent patency rates | During the follow-up, there was no thrombosis in the stent and complications related to portal hypertension caused by stent occlusion. | From receiving TIPS to 1 year after the end of treatment |
| The 2- year stent patency rates |
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Inclusion Criteria:
Exclusion Criteria:
6. Uncontrollable systemic infection or inflammation 7. Severe pulmonary hypertension 8. Severe renal insufficiency (except hepatogenic renal insufficiency) 9. Rapidly progressing liver failure 10. Contrast agent allergy 11. History of liver transplantation or allogeneic organ transplantation 12. Have a history of TIPS or shunt operation. 13. Pregnancy or lactation 14. Poor compliance 15. Participate in another clinical study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huzheng Yan, doctor | Contact | 8613610176039 | 131610176039 | yanhzhdr@163.com |
| Mingsheng Huang, doctor | Contact | +8613600004855 | huangmsh@mail.sysu.edu.cn |
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Incidence of rebleeding in 1 year and 2 years, incidence of overt hepatic encephalopathy in 1 year and 2 years, stent failure, incidence of hepatic encephalopathy, liver function (C-P score, ABI score), and overall survival.
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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|
| During TIPS operation, shunt diameter or diameter of covered stent | Device | After successful puncture, in the 8-mm shunt group, a balloon with a diameter of 6 mm was used to expand the shunt, and then an 8-mm covered stent was implanted (Viatorr; WL Gore & Associates, Inc.). |
|
During the follow-up, there was no thrombosis in the stent and complications related to portal hypertension caused by stent occlusion. |
| From receiving TIPS to 2 year after the end of treatment |
| The 1-year cumulative incidences of overt HE | HE greater than or equal to 2 | From receiving TIPS to 1 year after the end of treatment |
| The 2-year cumulative incidences of overt HE | HE greater than or equal to 2 | From receiving TIPS to 2 year after the end of treatment |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |