Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection.
Administration, Oral
Aged
Cytokines
/ blood
Embolization, Therapeutic
/ methods
Female
Gastrointestinal Agents
/ administration & dosage
Hepatectomy
/ methods
Humans
Liver
/ enzymology
Liver Function Tests
Liver Neoplasms
/ surgery
Liver Regeneration
/ drug effects
Male
Middle Aged
Organ Size
Perioperative Period
Portal Vein
Rifaximin
/ administration & dosage
Treatment Outcome
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
09 09 2021
09 09 2021
Historique:
received:
11
04
2021
accepted:
18
08
2021
entrez:
10
9
2021
pubmed:
11
9
2021
medline:
16
11
2021
Statut:
epublish
Résumé
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).
Identifiants
pubmed: 34504196
doi: 10.1038/s41598-021-97442-w
pii: 10.1038/s41598-021-97442-w
pmc: PMC8429542
doi:
Substances chimiques
Cytokines
0
Gastrointestinal Agents
0
Rifaximin
L36O5T016N
Banques de données
ClinicalTrials.gov
['NCT02555293']
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
17936Informations de copyright
© 2021. The Author(s).
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