Evidence map›Paper›PMID 33372103›Full record

Trial reportBMJ open gastroenterology2020

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).

K de Wit, J J Schaapman, F Nevens, J Verbeek, S Coenen, F J C Cuperus, M Kramer, E T T L Tjwa, N Mostafavi, M G W Dijkgraaf and 4 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04073290 (Prevention of Hepatic Encephalopathy by Administration of Rifaximin and Lactulose in Patients With Liver Cirrhosis Undergoing TIPS Placement), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04073290 phase4recruitingnot on this map

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.

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2020 to 2026Enrolled238ConditionsHepatic Encephalopathy, Cirrhosis, Liver, Portal Hypertension, Liver DiseasesArmsRifaximin 550 milligram Oral Tablet [XIFAXAN], Placebo oral tablet, Lactulose 667 milligram/milliliter Oral Solution
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Effect of a specificWorld journal of hepatology · 2022
    Trial
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  17. Innovative approaches to the management of ascites in cirrhosis.JHEP reports : innovation in hepatology · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 2 countries.

K de WitGastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.ORCID 0000-0001-8472-8549
J J SchaapmanGastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
F NevensGastroenterology and Hepatology, University Hospitals KU Leuven, Leuven, Belgium.
J VerbeekGastroenterology and Hepatology, University Hospitals KU Leuven, Leuven, Belgium.
S CoenenGastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.
F J C CuperusGastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.
M KramerDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.
E T T L TjwaGastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
N MostafaviBiostatistics Unit, Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
M G W DijkgraafEpidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
O M van DeldenInterventional Radiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
U H W BeuersGastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
M J CoenraadGastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
R B TakkenbergGastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands r.b.takkenberg@amsterdamumc.nl.
Amsterdam University Medical Centers · NLKU Leuven · BELeiden University Medical Center · NLErasmus MC · NLMaastricht University · NLRadboud University Nijmegen · NLUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCirrhotic patients with portal hypertension can suffer from variceal bleeding or refractory ascites and can benefit from a transjugular intrahepatic portosystemic shunt (TIPS). Post-TIPS hepatic encephalopathy (HE) is a common (20%-54%) and often severe complication. A prophylactic strategy is lacking. METHODS AND ANALYSIS: The Prevention of hepatic Encephalopathy by Administration of Rifaximin and Lactulose in patients with liver cirrhosis undergoing placement of a TIPS (PEARL) trial, is a multicentre randomised, double blind, placebo controlled trial. Patients undergoing covered TIPS placement are prescribed either rifaximin 550 mg two times per day and lactulose 25 mL two times per day (starting dose) or placebo 550 mg two times per day and lactulose 25 mL two times per day from 72 hours before and until 3 months after TIPS placement. Primary endpoint is the development of overt HE (OHE) within 3 months (according to West Haven criteria). Secondary endpoints include 90-day mortality; development of a second episode of OHE; time to development of episode(s) of OHE; development of minimal HE; molecular changes in peripheral and portal blood samples; quality of life and cost-effectiveness. The total sample size is 238 patients and recruitment period is 3 years in six hospitals in the Netherlands and one in Belgium. ETHICS AND DISSEMINATION: This study protocol was approved in the Netherlands by the Medical Research Ethics Committee of the Academic Medical Centre, Amsterdam (2018-332), in Belgium by the Ethics Committee Research UZ/KU Leuven (S62577) and competent authorities. This study will be conducted in accordance with Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. Study results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov (NCT04073290) and EudraCT database (2018-004323-37).

Indexed as

Esophageal and Gastric VaricesHepatic EncephalopathyPortasystemic Shunt, Transjugular IntrahepaticGastrointestinal HemorrhageHumansLactuloseLiver CirrhosisQuality of LifeRifaximinLactuloseRifaximinhepatic encephalopathyliver cirrhosisportal hypertension

Identifiers

PMID33372103
PMCPMC7783616
OpenAlexW3117644001

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.