Clinical trial · Interventional
Standard of Care Versus Hemopatch® During Liver Resection
Standard of Care Versus a New Collagen and Polyethylene Glycol Haemostatic/Sealant Patch (Hemopatch) During Liver Resection. A Multicentre, Non-inferiority Prospective Randomized Study (IBERLIVER-study)
NCT03166683CI-TRIAL-00030268IBERLIVERunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Leak | — | UNRESOLVED | — |
| Hemorrhage Liver | — | UNRESOLVED | — |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
| Tumor Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemopatch | Other | — | UNRESOLVED |
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hemopatch
- description
- Use of hemopatch like a control of bile leakage/sealant during liver resection surgery.
- interventionNames
- Other: Hemopatch
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Application of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery.
- interventionNames
- Other: Standard of care
Primary outcomes (1)
- measure
- Control of bile leakage
- timeFrame
- From day 1 to day 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: ≥18 years. * Patients with an indication for open liver resection (segmental or non-segmental). * Target bleeding site of generalized bleeding that persists on the cut surface of the liver in which hemostasis cannot be achieved by conventional methods. * Willing and able to complete the clinical trial procedures, as described in the protocol. * Signed written informed consent to participate in this clinical trial. Exclusion Criteria: * Presence of coagulation disorder, Klatskin tumour. Cirrhosis, re-hepatectomies and biliary resections * Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints. * Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamic acid, activated factor VII, fibrinogen and aprotinin. * Known allergy or hypersensitivity to a component of the investigational treatments Hemopatch® ,to riboflavin or to proteins of bovine origin. * Pregnancy or breast-feeding. * Inability to understand the nature and the extent of the trial and the procedures required. Criteria to be checked during surgery (intraoperative exclusion criteria): * Infected wound area. * Persistent major bleeding after primary hemostasis.
References
Publications (15)
- BACKGROUNDBaumgartner B, Draxler W, Lewis KM. Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy. J Invest Surg. 2016 Dec;29(6):343-351. doi: 10.3109/08941939.2016.1154627. Epub 2016 Mar 22. PMID 27002742
- BACKGROUNDErdogan D, Busch OR, van Delden OM, Rauws EA, Gouma DJ, van Gulik TM. Incidence and management of bile leakage after partial liver resection. Dig Surg. 2008;25(1):60-6. doi: 10.1159/000118024. Epub 2008 Feb 22. PMID 18292662
- BACKGROUNDFigueras J, Llado L, Miro M, Ramos E, Torras J, Fabregat J, Serrano T. Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients. Ann Surg. 2007 Apr;245(4):536-42. doi: 10.1097/01.sla.0000245846.37046.57. PMID 17414601
- BACKGROUNDGuillaud A, Pery C, Campillo B, Lourdais A, Sulpice L, Boudjema K. Incidence and predictive factors of clinically relevant bile leakage in the modern era of liver resections. HPB (Oxford). 2013 Mar;15(3):224-9. doi: 10.1111/j.1477-2574.2012.00580.x. Epub 2012 Oct 4. PMID 23374363
- BACKGROUNDLewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014 Mar 4;2014:930803. doi: 10.1155/2014/930803. eCollection 2014. PMID 24729905
- BACKGROUNDLewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6. PMID 25106082
- BACKGROUNDLewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub 2014 Aug 1.