Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation

Hepatic Encephalopathy Clinical Trial

— DM-PTHE  

Official title:

Effect of Diet Management on Incidence of Hepatic Encephalopathy of Patients With Cirrhosis and Variceal Bleeding After Transjugular Intrahepatic Portosystemic Shunt Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03372499
• Other study ID #: DM-PTHE
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2017
• Last updated: December 8, 2017
• Start date: October 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: West China Hospital
• Contact: Li Yang, MD
• Phone: +86 18980601276
• Email: yangli_hx[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with decompensated liver cirrhosis regardless of the etiology

• acute variceal bleeding or with history of variceal bleeding evidenced by endoscopy

• an age between 18 and 75 years old

Exclusion Criteria:

• a total bilirubin level more than 3mg/dL (51.3mmol/L)

• a creatinine level greater than 3 mg/dL(265umol/L)

• severe dysfunction of heart and respiratory system

• pregnancy

• uncontrolled neoplasm

• active systemic infection

• history of any kind of encephalopathy, mental disease, alcohol dependence, or any other status that influence brain function

• diabetes or any other metabolic diseases

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Dietary Supplement:
• diet management strategy for encephalopathy
diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Li Yang	West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (16)

Abdelsayed GG. Diets in Encephalopathy. Clin Liver Dis. 2015 Aug;19(3):497-505. doi: 10.1016/j.cld.2015.05.001. Review. — View Citation

Berlioux P, Robic MA, Poirson H, Métivier S, Otal P, Barret C, Lopez F, Péron 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Rössle 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hepatic Encephalopathy	incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment	1 year
Secondary	Liver Transplantation-free Survival Rate	survival rate free of liver transplantation within 1 year after enrollment	1 year
Secondary	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.	1 year
Secondary	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
Secondary	Change of Nutritional Status	Human body components analysis, evaluated by score of the Inbody Test.	1 year
Secondary	Change of Quality of Life	Health related quality of life, assessed by score of the widely used questionaire Short Form 36.	1 year