NCT03372499

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

November 8, 2017

Last Update Submit

December 8, 2017

Conditions

Hepatic Encephalopathy

Keywords

Hepatic EncephalopathyDiet ManagementTransjugular Intrahepatic Portosystemic Shunt

Outcome Measures

Primary Outcomes (1)

  • Incidence of Hepatic Encephalopathy

    incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment

    1 year

Secondary Outcomes (5)

  • Liver Transplantation-free Survival Rate

    1 year

  • Incidence of Stent Dysfunction

    1 year

  • Incidence of Portal Hypertension Related Severe Complications

    1 year

  • Change of Nutritional Status

    1 year

  • Change of Quality of Life

    1 year

Study Arms (2)

nutritional management group

EXPERIMENTAL

diet management strategy for encephalopathy

Dietary Supplement: 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

Interventions

diet management strategy for encephalopathyDIETARY_SUPPLEMENT

diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.

nutritional management group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, +86, China

RECRUITING

Related Publications (16)

  • 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.

    PMID: 23811307BACKGROUND

  • 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.

    PMID: 7717309BACKGROUND

  • 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.

    PMID: 28051803BACKGROUND

  • 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.

    PMID: 27440683BACKGROUND

  • 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.

    PMID: 26925879BACKGROUND

  • 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.

    PMID: 18775022BACKGROUND

  • 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.

    PMID: 15826716BACKGROUND

  • 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.

    PMID: 20537753BACKGROUND

  • 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.

    PMID: 22321469BACKGROUND

  • 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.

    PMID: 21039832BACKGROUND

  • 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.

    PMID: 18440957BACKGROUND

  • 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.

    PMID: 27377741BACKGROUND

  • 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.

    PMID: 24620380BACKGROUND

  • 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.

    PMID: 11808942BACKGROUND

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

    PMID: 26195204BACKGROUND

  • 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.

    PMID: 20822500BACKGROUND

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Li Yang, MD

    Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University

    STUDY DIRECTOR

Central Study Contacts

Li Yang, MD

CONTACT

+86 18980601276yangli_hx@scu.edu.cn

Yongjun Zhu, Doctor

CONTACT

+86 13281121937hp545204493@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 8, 2017

First Posted

December 13, 2017

Study Start

October 1, 2017

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

CN(1)