🏛️ Verified NIH Record • Updated 2026-06-03

Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy (NCT07634237)

🟡 Not Yet Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (12 items).

Location: McGill University Health Centre — Montreal, Quebec

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • McGill University Health Centre — Montreal, Quebec

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗