Role of Sarcopenia and Nutritional/Physical Therapy Intervention in Post-TIPS Hepatic Encephalopathy

NCT05346029 | Unknown

• 1 other identifier: PI21/00131
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

The placement of TIPS (transjugular intrahepatic portosystemic shunt) is the most effective strategy to treat complications of portal hypertension. However, the threat of developing post-TIPS complications diminishes its use and applicability. Hepatic encephalopathy (HE) is the most feared and frequent post-TIPS complication, affecting between 25-54% of patients. Available treatments against HE are only partially effective. Therefore, the best existing strategy is to accurately select patients for TIPS excluding those presenting known high risk factors associated to post-TIPS HE. Despite applying this approach, the incidence of post-TIPS HE still remains very high. The investigators hypothesize that a better identification of risk factors for post-TIPS HE, together with the introduction of therapeutic interventions modulating pathophysiological mechanisms involved in post-TIPS HE development - among which sarcopenia stands out- would lead to a reduction in the incidence of HE and, eventually, to an increase in the number of patients benefiting from TIPS. Thus, our project is aimed at

1. 1.Demonstrate that a 12 weeks lifestyle intervention based on resistance training and nutritional counseling can reduce sarcopenia and, ultimately, post-TIPS HE.
2. 2.To study predictive factors of post-TIPS HE, focusing on the role of factors that have never been evaluated in the setting of TIPS: gut microbiome and cognitive function

Conditions

Cirrhosis, Liver; Hepatic Encephalopathy; Sarcopenia

Keywords

Transjugular intrahepatic portosystemic shunt (TIPS); sarcopenia; microbioma; physical therapy; nutrition; hepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

• Development of post-TIPS overt HE within 6 months after TIPS placement

  Overt HE will be defined if any grade from 2 to 4 of West Haven Criteria are present: grade 2, fatigue, apathy, flapping tremor, ataxia, slurred speech; grade 3, somnolence, marked disorientation, rigor, stupor; grade 4, coma.

  6 months

Secondary Outcomes (11)

• 6 months mortality;

  6 months

• development of a second episode of overt HE within the first 6 month

  6 months

• development of minimal HE within the first 6 months

  6 months

• development of minimal HE within the first 6 months

  6 months

• development of minimal HE within the first 6 months

  6 months

Study Arms (2)

Standard of care

NO INTERVENTION

Patients will be followed-up according to standard clinical practices

Lifestyle intervention

EXPERIMENTAL

Patients will undergo a 12 week lifestyle intervention (physical therapy and nutritional assessment)

Behavioral: Lifestyle intervention

Interventions

Lifestyle intervention BEHAVIORAL

Resistance training and nutritional counseling

Lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cirrhotic patients submitted for elective TIPS

You may not qualify if:

• Contraindication for TIPS placement, contraindication for physical therapy

Sponsors & Collaborators

• Anna Baiges: lead
• Instituto de Salud Carlos III: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Gregorio Marañón Hospital: collaborator

Study Sites (3)

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, Spain

RECRUITING

Related Publications (8)

• Goldbecker A, Weissenborn K, Hamidi Shahrezaei G, Afshar K, Rumke S, Barg-Hock H, Strassburg CP, Hecker H, Tryc AB. Comparison of the most favoured methods for the diagnosis of hepatic encephalopathy in liver transplantation candidates. Gut. 2013 Oct;62(10):1497-504. doi: 10.1136/gutjnl-2012-303262. Epub 2013 Jan 7.

  PMID: 23297006 RESULT

• Lauridsen MM, Jepsen P, Vilstrup H. Critical flicker frequency and continuous reaction times for the diagnosis of minimal hepatic encephalopathy: a comparative study of 154 patients with liver disease. Metab Brain Dis. 2011 Jun;26(2):135-9. doi: 10.1007/s11011-011-9242-1. Epub 2011 Apr 12.

  PMID: 21484318 RESULT

• Riggio O, Merlli M, Pedretti G, Servi R, Meddi P, Lionetti R, Rossi P, Bezzi M, Salvatori F, Ugolotti U, Fiaccadori F, Capocaccia L. Hepatic encephalopathy after transjugular intrahepatic portosystemic shunt. Incidence and risk factors. Dig Dis Sci. 1996 Mar;41(3):578-84. doi: 10.1007/BF02282344.

  PMID: 8617139 RESULT

• Nardelli S, Lattanzi B, Torrisi S, Greco F, Farcomeni A, Gioia S, Merli M, Riggio O. Sarcopenia Is Risk Factor for Development of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Placement. Clin Gastroenterol Hepatol. 2017 Jun;15(6):934-936. doi: 10.1016/j.cgh.2016.10.028. Epub 2016 Nov 2.

  PMID: 27816756 RESULT

• Merli M, Giusto M, Lucidi C, Giannelli V, Pentassuglio I, Di Gregorio V, Lattanzi B, Riggio O. Muscle depletion increases the risk of overt and minimal hepatic encephalopathy: results of a prospective study. Metab Brain Dis. 2013 Jun;28(2):281-4. doi: 10.1007/s11011-012-9365-z. Epub 2012 Dec 7.

  PMID: 23224378 RESULT

• Gioia S, Merli M, Nardelli S, Lattanzi B, Pitocchi F, Ridola L, Riggio O. The modification of quantity and quality of muscle mass improves the cognitive impairment after TIPS. Liver Int. 2019 May;39(5):871-877. doi: 10.1111/liv.14050. Epub 2019 Feb 6.

  PMID: 30667572 RESULT

• Aamann L, Dam G, Borre M, Drljevic-Nielsen A, Overgaard K, Andersen H, Vilstrup H, Aagaard NK. Resistance Training Increases Muscle Strength and Muscle Size in Patients With Liver Cirrhosis. Clin Gastroenterol Hepatol. 2020 May;18(5):1179-1187.e6. doi: 10.1016/j.cgh.2019.07.058. Epub 2019 Aug 5.

  PMID: 31394282 RESULT

• Bajaj JS, Betrapally NS, Gillevet PM. Decompensated cirrhosis and microbiome interpretation. Nature. 2015 Sep 17;525(7569):E1-2. doi: 10.1038/nature14851. No abstract available.

  PMID: 26381988 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Encephalopathy; Sarcopenia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Anna Baiges, MD, PHD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Baiges, MD, PhD

CONTACT

93 227 54 00; abaigesa@clinic.cat

Joan Carles García Pagan, MD, PhD

CONTACT

93 227 54 00; jcgarcia@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention (physical therapy and nutritional optimization) there is no masking in this study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to standard medical care or to intervention group for the duration of the study

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 26, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)