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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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Hepatic encephalopathy is a severe complication of transjugular intrahepatic portosystemic shunt (TIPS) treatment in patients with cirrhosis and variceal bleeding. This study is specially designed to explore whether diet management strategy could decrease incidence of encephalopathy after TIPS treatment.
Hepatic encephalopathy (HE) is a severe complication of TIPS treatment in patients with cirrhosis and variceal bleeding. The overall incidence of post-TIPS encephalopathy ranges between 10% and 50%, and even the percentage of the new or worsened HE was evaluated up to 13-36%. No approach or medication was evidenced for prophylaxis of post-TIPS encephalopathy, including lactulose and rifaximin. Diet management has been used as an important part of the prophylaxis and treatment strategy for patients with metabolic diseases like diabetes and nephritis, which has drawn increasing interest of clinicians. Nevertheless, there is still no standard consensus or even recommendation for patients after TIPS procedure for now, which worsened malnutrition and affected survival. Thus, this study is specially designed to explore whether diet management strategy, drawn up from the nutritional management consensus of hepatic encephalopathy (ISHEN consensus), could decrease incidence of encephalopathy after TIPS treatment of the patient with cirrhosis and variceal bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutritional management group | Experimental | diet management strategy for encephalopathy |
|
| control group | No Intervention | Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet management strategy for encephalopathy | Dietary Supplement | diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hepatic Encephalopathy | incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Transplantation-free Survival Rate | survival rate free of liver transplantation within 1 year after enrollment | 1 year |
| Incidence of Stent Dysfunction | Narrowing or even complete occlusion of the stent, evidenced by imaging examination and/or upper gastrointestinal endoscopy, with or without clinic symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Yang, MD | Contact | +86 18980601276 | yangli_hx@scu.edu.cn | |
| Yongjun Zhu, Doctor | Contact | +86 13281121937 | hp545204493@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Yang, MD | Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | +86 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23811307 | Background | Rossle M. TIPS: 25 years later. J Hepatol. 2013 Nov;59(5):1081-93. doi: 10.1016/j.jhep.2013.06.014. Epub 2013 Jun 25. | |
| 7717309 | Background | Somberg KA, Riegler JL, LaBerge JM, Doherty-Simor MM, Bachetti P, Roberts JP, Lake JR. Hepatic encephalopathy after transjugular intrahepatic portosystemic shunts: incidence and risk factors. Am J Gastroenterol. 1995 Apr;90(4):549-55. |
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The investigators need to discuss with other participants whether or not to share data of the study.
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| 1 year |
| Incidence of Portal Hypertension Related Severe Complications | Incidence of severe complications of portal hypertension, especially for failure of control of acute variceal bleeding and clinical significant rebleeding. | 1 year |
| Change of Nutritional Status | Human body components analysis, evaluated by score of the Inbody Test. | 1 year |
| Change of Quality of Life | Health related quality of life, assessed by score of the widely used questionaire Short Form 36. | 1 year |
| 28051803 | Background | Routhu M, Safka V, Routhu SK, Fejfar T, Jirkovsky V, Krajina A, Cermakova E, Hosak L, Hulek P. Observational cohort study of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt (TIPS). Ann Hepatol. 2017 Jan-Feb;16(1):140-148. doi: 10.5604/16652681.1226932. |
| 27440683 | Background | Luo L, Fu S, Zhang Y, Wang J. Early diet intervention to reduce the incidence of hepatic encephalopathy in cirrhosis patients: post-Transjugular Intrahepatic Portosystemic Shunt (TIPS) findings. Asia Pac J Clin Nutr. 2016;25(3):497-503. doi: 10.6133/apjcn.092015.14. |
| 26925879 | Background | Nardelli S, Gioia S, Pasquale C, Pentassuglio I, Farcomeni A, Merli M, Salvatori FM, Nikolli L, Torrisi S, Greco F, Nicoletti V, Riggio O. Cognitive Impairment Predicts The Occurrence Of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt. Am J Gastroenterol. 2016 Apr;111(4):523-8. doi: 10.1038/ajg.2016.29. Epub 2016 Mar 1. |
| 18775022 | Background | Riggio O, Angeloni S, Salvatori FM, De Santis A, Cerini F, Farcomeni A, Attili AF, Merli M. Incidence, natural history, and risk factors of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt with polytetrafluoroethylene-covered stent grafts. Am J Gastroenterol. 2008 Nov;103(11):2738-46. doi: 10.1111/j.1572-0241.2008.02102.x. Epub 2008 Sep 4. |
| 15826716 | Background | Riggio O, Masini A, Efrati C, Nicolao F, Angeloni S, Salvatori FM, Bezzi M, Attili AF, Merli M. Pharmacological prophylaxis of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt: a randomized controlled study. J Hepatol. 2005 May;42(5):674-9. doi: 10.1016/j.jhep.2004.12.028. |
| 20537753 | Background | Riggio O, Ridola L, Angeloni S, Cerini F, Pasquale C, Attili AF, Fanelli F, Merli M, Salvatori FM. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27. |
| 22321469 | Background | Riggio O, Nardelli S, Moscucci F, Pasquale C, Ridola L, Merli M. Hepatic encephalopathy after transjugular intrahepatic portosystemic shunt. Clin Liver Dis. 2012 Feb;16(1):133-46. doi: 10.1016/j.cld.2011.12.008. Epub 2012 Jan 4. |
| 21039832 | Background | Yang Z, Han G, Wu Q, Ye X, Jin Z, Yin Z, Qi X, Bai M, Wu K, Fan D. Patency and clinical outcomes of transjugular intrahepatic portosystemic shunt with polytetrafluoroethylene-covered stents versus bare stents: a meta-analysis. J Gastroenterol Hepatol. 2010 Nov;25(11):1718-25. doi: 10.1111/j.1440-1746.2010.06400.x. |
| 18440957 | Background | Masson S, Mardini HA, Rose JD, Record CO. Hepatic encephalopathy after transjugular intrahepatic portosystemic shunt insertion: a decade of experience. QJM. 2008 Jun;101(6):493-501. doi: 10.1093/qjmed/hcn037. Epub 2008 Apr 25. |
| 27377741 | Background | Suraweera D, Sundaram V, Saab S. Evaluation and Management of Hepatic Encephalopathy: Current Status and Future Directions. Gut Liver. 2016 Jul 15;10(4):509-19. doi: 10.5009/gnl15419. |
| 24620380 | Background | Berlioux P, Robic MA, Poirson H, Metivier S, Otal P, Barret C, Lopez F, Peron JM, Vinel JP, Bureau C. Pre-transjugular intrahepatic portosystemic shunts (TIPS) prediction of post-TIPS overt hepatic encephalopathy: the critical flicker frequency is more accurate than psychometric tests. Hepatology. 2014 Feb;59(2):622-9. doi: 10.1002/hep.26684. |
| 11808942 | Background | Kramer L, Bauer E, Gendo A, Funk G, Madl C, Pidlich J, Gangl A. Neurophysiological evidence of cognitive impairment in patients without hepatic encephalopathy after transjugular intrahepatic portosystemic shunts. Am J Gastroenterol. 2002 Jan;97(1):162-6. doi: 10.1111/j.1572-0241.2002.05441.x. |
| 26195204 | Background | Abdelsayed GG. Diets in Encephalopathy. Clin Liver Dis. 2015 Aug;19(3):497-505. doi: 10.1016/j.cld.2015.05.001. |
| 20822500 | Background | Takuma Y, Nouso K, Makino Y, Hayashi M, Takahashi H. Clinical trial: oral zinc in hepatic encephalopathy. Aliment Pharmacol Ther. 2010 Nov;32(9):1080-90. doi: 10.1111/j.1365-2036.2010.04448.x. Epub 2010 Sep 3. |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |