Evidence map›Paper›PMID 34504196›Full record

Trial reportScientific reports2021

Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection.

Jan Bednarsch, Zoltan Czigany, Sven H Loosen, Lara Heij, Lorenz Ruckgaber, Henning Maes, Jan-Pit Krause, Matthias Reen, Beata Toteva, Theresa Vosdellen and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02555293 (Administration of Rifaximin to Improve Liver Regeneration and Outcome Following Major Liver Resection), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 45% 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.

NCT02555293 phase2terminatednot on this map

Administration of Rifaximin to Improve Liver Regeneration and Outcome Following Major Liver Resection

TypeinterventionalSponsorRWTH Aachen UniversityRan2016 to 2020Enrolled96ConditionsMalignant Liver Disease, Major Liver ResectionArmsXIFAXAN® (Rifaximin)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Article
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

16 authors at 2 institutions in 2 countries.

Jan BednarschDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Zoltan CziganyDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Sven H LoosenDepartment of Medicine III, University Hospital RWTH Aachen, Aachen, Germany.
Lara HeijDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Lorenz RuckgaberDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Henning MaesDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Jan-Pit KrauseDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Matthias ReenDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Beata TotevaDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Theresa VosdellenDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Philipp BrunersDepartment of Radiology, University Hospital RWTH Aachen, Aachen, Germany.
Sven Arke LangDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Tom Florian UlmerDepartment of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Christoph RoderburgDepartment of Medicine III, University Hospital RWTH Aachen, Aachen, Germany.
Tom Luedde *Department of Medicine III, University Hospital RWTH Aachen, Aachen, Germany.
Ulf Peter Neumann *Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany. uneumann@ukaachen.de.
RWTH Aachen University · DEDüsseldorf University Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7-10 or 14-21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).

Indexed as

Perioperative PeriodAdministration, OralAgedCytokinesEmbolization, TherapeuticFemaleGastrointestinal AgentsHepatectomyHumansLiverLiver Function TestsLiver NeoplasmsLiver RegenerationMaleMiddle AgedOrgan SizeCytokinesGastrointestinal AgentsRifaximin

Identifiers

PMID34504196
PMCPMC8429542
OpenAlexW3197589872

What OpenQuestion holds

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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.