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

NCT ID: NCT03372499

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatic Encephalopathy

Keywords

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Hepatic Encephalopathy Diet Management Transjugular Intrahepatic Portosystemic Shunt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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nutritional management group

diet management strategy for encephalopathy

Group Type EXPERIMENTAL

diet management strategy for encephalopathy

Intervention Type DIETARY_SUPPLEMENT

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

control group

Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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diet management strategy for encephalopathy

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role collaborator

Li Yang

OTHER

Sponsor Role lead

Responsible Party

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Li Yang

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Yang, MD

Role: STUDY_DIRECTOR

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

Locations

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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Yang, MD

Role: CONTACT

Phone: +86 18980601276

Email: [email protected]

Yongjun Zhu, Doctor

Role: CONTACT

Phone: +86 13281121937

Email: [email protected]

Facility Contacts

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Li Yang, MD

Role: primary

Yongjun Zhu, Doctor

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 23811307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7717309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28051803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27440683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26925879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18775022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15826716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20537753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22321469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21039832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18440957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27377741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24620380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11808942 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26195204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20822500 (View on PubMed)

Other Identifiers

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DM-PTHE

Identifier Type: -

Identifier Source: org_study_id