Related Experiment Video
Updated: May 25, 2026
Application of Hemostatic Devices in Laparoscopic Hepatectomy
Published on: April 19, 2022
Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled
James V Guarrera1, Navpreet Kaur2, Cornelis Verhoef3
1Department of Surgery, Sidney Kimmel Medical College at Thomas Jefferson University, 1025 Walnut Street, Suite 607, Philadelphia, PA, 19107, USA; Department of Surgery, Division of Liver Transplant and Hepatobiliary Surgery, Rutgers New Jersey Medical School and University Hospital, 140 Bergen Street, Newark, NJ, 07101, USA.
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.