PEARL
Prevention of Hepatic Encephalopathy by Administration of Rifaximin and Lactulose in Patients With Liver Cirrhosis Undergoing TIPS Placement: a Multi-centre Randomized, Double Blind, Placebo Controlled Trial.
Sponsor study identifier
Secondary identifiers
interventional
238
2 countries
6
Study Start
January 21, 2020
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 27, 2019
Actual (reported)August 29, 2019
Actual (reported)January 21, 2020
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
post-TIPS Hepatic Encephalopathy
post-TIPS Hepatic Encephalopathy
First 3 months after TIPS placement
Mortality
90 days
Transplant free survival
One year
time to development of post-TIPS HE episode(s)
One year
Rifaximin 550 milligram b.i.d. combined with lactulose
Placebo b.i.d. combined with lactulose
Rifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
Placebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
RIFAXIMIN ALFASIGMA 550 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
RIFAXIMIN ALFASIGMA 550 mg film-coated tablets
Named ingredient: Rifaximin
View registry recordUniversitaire Ziekenhuizen Leuven
Leuven, Belgium
Academic Medical Centre
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
de Wit K, Schaapman JJ, Nevens F, Verbeek J, Coenen S, Cuperus FJC, Kramer M, Tjwa ETTL, Mostafavi N, Dijkgraaf MGW, van Delden OM, Beuers UHW, Coenraad MJ, Takkenberg RB. Prevention of hepatic encephalopathy by administration of rifaximin and lactulose in patients with liver cirrhosis undergoing placement of a transjugular intrahepatic portosystemic shunt (TIPS): a multicentre randomised, double blind, placebo controlled trial (PEARL trial). BMJ Open Gastroenterol. 2020 Dec;7(1):e000531. doi: 10.1136/bmjgast-2020-000531.
Bart Takkenberg, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First Submitted
August 27, 2019
First Posted
August 29, 2019
Study Start
January 21, 2020
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
development of a second episode of post-TIPS HE
3 months
development of post-TIPS HE between 3-12 months after TIPS placement
3-12 months
Health related Quality of life
One year
Disease rrelated Quality of life
One year
Cost-effectiveness
One year
Lactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS
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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Leiden University Medical Center
Leiden, Netherlands
Radboud University
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 28, 2025
Record last verified: 2025-01
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