Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy

NCT07634237 | Not Yet Recruiting DMC

• 1 other identifier: MP-37-2025-10963
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.

Conditions

Cirrhosis; Refractory Ascites; TIPS Insertion

Keywords

Personalized Nutritional Intervention; Overt Hepatic Encephalopathy; Cirrhosis; Refractory Ascites; TIPS Insertion

Outcome Measures

Primary Outcomes (1)

• Incidence of overt hepatic encephalopathy

  6 months

Secondary Outcomes (4)

• Changes in nutritional status using the PG-SGA scale

  6 months

• Changes in brain function using the Stroop Test (EncephalApp)

  6 months

• Changes in frailty using the Liver Frailty Index

  6 months

• Changes in patient-reported outcomes using Chronic Liver Disease Questionnaire

  6 months

Other Outcomes (1)

• Feasibility outcomes including recruitment rate and study completion

  6 months

Study Arms (2)

Nutrition Intervention 1

EXPERIMENTAL

As participants are blinded, description of the arm is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.

Dietary Supplement: High Energy and High Protein Diet 1

Nutrition Intervention 2

ACTIVE COMPARATOR

As participants are blinded, description of the arm is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.

Dietary Supplement: High Energy and High Protein Diet 2

Interventions

High Energy and High Protein Diet 1 DIETARY_SUPPLEMENT

As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.

Nutrition Intervention 1

High Energy and High Protein Diet 2 DIETARY_SUPPLEMENT

As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.

Nutrition Intervention 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cirrhosis
• TIPS planned for refractory ascites
• Being at least moderately malnourished

You may not qualify if:

• TIPS insertion for other reason than refractory ascites
• Budd Chiari Syndrome
• Complete or cavernomatous portal vein thrombosis
• Pre-TIPS recurrent or persistent overt hepatic encephalopathy
• Use of lactulose or rifaximin in the last 4 weeks
• Liver failure (MELD \> 18 or Child Pugh score \> 12)
• Heart failure (NYHA ≥ III or LVEF \< 50%)
• Kidney failure (serum creatinine \> 250µmol/L)
• Pregnancy or breastfeeding
• Previous Liver transplantation
• Unable to provide informed consent

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Fibrosis; Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amine Benmassaoud, MD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nassim Oumansour, BSc

CONTACT

514-934-1934; nassim.oumansour@rimuhc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: June 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): December 15, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CA (1)