HPB : the official journal of the International Hepato Pancreato Biliary Association · 2026
Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled multicenter trial.
Сравнительное исследованиеEquivalence TrialСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Guarrera James V, Kaur Navpreet, Verhoef Cornelis, Zendejas Ivan, Botha Jean, Fouraschen Suomi M G, Paterno Flavio, Pianka Frank, Porte Robert J, Samstein Benjamin, Sher Linda, Wellen Jason R, Bender Johan C M E, Fossan Ingrid, Head Stuart J, de Wilt Johannes H W, ETHIZIA Open Liver Study Collaborator Group
Аннотация
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.
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.