Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled multicenter trial.
Publication/Presentation Date
8-1-2026
Abstract
BACKGROUND: Liver surgery carries a significant risk of perioperative bleeding. This randomized clinical trial compared the safety and efficacy of ETHIZIA, a novel, highly adaptable hemostatic patch, to the current standard of care during open liver surgery.
METHODS: Adult subjects (N = 132) were randomized 2:1 to ETHIZIA or TachoSil to treat one or more target bleeding sites (TBS) on the liver transection plane. The objective was to demonstrate non-inferiority (margin 10%) and subsequently, superiority, of ETHIZIA to TachoSil in hemostatic success at 3 min post-application.
RESULTS: For the first-treated TBS (Per protocol set, ETHIZIA N = 87, TachoSil N = 43), 3-min hemostatic success was both non-inferior (p < 0.0001) and superior (p = 0.0038) for ETHIZIA (93.1%) compared to TachoSil (76.7%); the median time to hemostasis was significantly shorter (0.5 versus 3.0 min, respectively (p < 0.0001)). Failure and rescue rates were lower for ETHIZIA (1.1% and 3.4%) than for TachoSil (7.0% and 11.6%). Efficacy results including additionally treated TBS were similar (ETHIZIA N = 139 TBS, TachoSil N = 59 TBS). Bile/non-bile fluid collections were more frequent in ETHIZIA-treated subjects, but multivariable regression indicated a multifactorial surgical basis and no association with hemostatic device.
CONCLUSION: Fast and robust hemostasis supports ETHIZIA as a valuable and safe new hemostatic agent during open liver surgery.
CLINICAL TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov as NCT05385952.
Volume
28
Issue
8
First Page
1064
Last Page
1075
ISSN
1477-2574
Published In/Presented At
Guarrera, J. V., Kaur, N., Verhoef, C., Zendejas, I., Botha, J., Fouraschen, S. M. G., Paterno, F., Pianka, F., Porte, R. J., Samstein, B., Sher, L., Wellen, J. R., Bender, J. C. M. E., Fossan, I., Head, S. J., de Wilt, J. H. W., & ETHIZIA Open Liver Study Collaborator Group (2026). Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled multicenter trial. HPB : the official journal of the International Hepato Pancreato Biliary Association, 28(8), 1064–1075. https://doi.org/10.1016/j.hpb.2026.04.466
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
42177141
Department(s)
Administration and Leadership
Document Type
Article