Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection
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...
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Nature Portfolio
2021
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oai:doaj.org-article:580da29a8174461383f251263e367a782021-12-02T14:58:48ZPerioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection10.1038/s41598-021-97442-w2045-2322https://doaj.org/article/580da29a8174461383f251263e367a782021-09-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-97442-whttps://doaj.org/toc/2045-2322Abstract 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).Jan BednarschZoltan CziganySven H. LoosenLara HeijLorenz RuckgaberHenning MaesJan-Pit KrauseMatthias ReenBeata TotevaTheresa VosdellenPhilipp BrunersSven Arke LangTom Florian UlmerChristoph RoderburgTom LueddeUlf Peter NeumannNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-12 (2021) |
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Medicine R Science Q Jan Bednarsch Zoltan Czigany Sven H. Loosen Lara Heij Lorenz Ruckgaber Henning Maes Jan-Pit Krause Matthias Reen Beata Toteva Theresa Vosdellen Philipp Bruners Sven Arke Lang Tom Florian Ulmer Christoph Roderburg Tom Luedde Ulf Peter Neumann Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection |
| description |
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). |
| format |
article |
| author |
Jan Bednarsch Zoltan Czigany Sven H. Loosen Lara Heij Lorenz Ruckgaber Henning Maes Jan-Pit Krause Matthias Reen Beata Toteva Theresa Vosdellen Philipp Bruners Sven Arke Lang Tom Florian Ulmer Christoph Roderburg Tom Luedde Ulf Peter Neumann |
| author_facet |
Jan Bednarsch Zoltan Czigany Sven H. Loosen Lara Heij Lorenz Ruckgaber Henning Maes Jan-Pit Krause Matthias Reen Beata Toteva Theresa Vosdellen Philipp Bruners Sven Arke Lang Tom Florian Ulmer Christoph Roderburg Tom Luedde Ulf Peter Neumann |
| author_sort |
Jan Bednarsch |
| title |
Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection |
| title_short |
Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection |
| title_full |
Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection |
| title_fullStr |
Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection |
| title_full_unstemmed |
Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection |
| title_sort |
perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection |
| publisher |
Nature Portfolio |
| publishDate |
2021 |
| url |
https://doaj.org/article/580da29a8174461383f251263e367a78 |
| work_keys_str_mv |
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1718389265913610240 |