Clinical trial · Interventional
Efficacy and Tolerability of Hemopatch After Hepatic Resection
Exploratory Phase IV Randomized Single Blind Study Evaluating the Efficacy and Tolerability of Hemopatch in Improving Time of Hemostasis and Preventing Post-operative Complications After Hepatic Resection
- 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)
* Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen. * Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost any bleeding surface encountered during a range of procedures. The Authors shown that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. They support the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries. * In a recent published case report the authors reported the feasibility in using Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the procedure on cardiopulmonary bypass, which meant the patient had to be heparinized. Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to contain bleeding and seal the wound without needing any suture. These initial results lead up to future randomized clinical trials with more extensive follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Metastatic | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Hemostasis | — | UNRESOLVED | — |
| Hepatectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Common Surgical Techniques | Procedure | — | UNRESOLVED |
| Hemopatch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hemopatch 45x90 mm - CE 0297 Class III
- description
- Hemopatch + Common surgical techniques
- interventionNames
- Device: Hemopatch
- type
- OTHER
- label
- Standard Surgery Technique
- description
- Common surgical techniques
- interventionNames
- Procedure: Common Surgical Techniques
Primary outcomes (1)
- measure
- Evaluated comparing the achievement of hemostasis within 3 minutes from the application of the patch
- timeFrame
- Day 0 - T3 (Surgery)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Hepatocellular carcinoma * Hilar cholangiocarcinoma * Adrenal cancer metastasis * Breast cancer metastasis * Colorectal cancer metastasis * Ovarian cancer metastasis * Biliary carcinoma * Hemangioma * Hepatic adenoma * Focal nodular hyperplasia * Unilocular hydatid cyst * Multilocular hydatid cyst Exclusion Criteria: * Trauma surgery * Active sepsis around the liver * Documented history of cirrhosis * Pregnant or nursing women * Severe coagulopathy (defined as an International normalized ratio \>2.0) * Severe Liver disfunction, as per clinical assessment * Previous liver transplantation * Laparoscopic procedure * Any other intraoperative finding, which defines the no eligibility of the patient for liver resection * Known hypersensitivity to bovine proteins or brilliant blue * Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
References
Publications (16)
- RESULTJarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3. PMID 12368667
- RESULTImamura H, Seyama Y, Kokudo N, Maema A, Sugawara Y, Sano K, Takayama T, Makuuchi M. One thousand fifty-six hepatectomies without mortality in 8 years. Arch Surg. 2003 Nov;138(11):1198-206; discussion 1206. doi: 10.1001/archsurg.138.11.1198. PMID 14609867
- RESULTPoon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective database. Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10. doi: 10.1097/01.sla.0000141195.66155.0c. PMID 15383797
- RESULTJones RM, Moulton CE, Hardy KJ. Central venous pressure and its effect on blood loss during liver resection. Br J Surg. 1998 Aug;85(8):1058-60. doi: 10.1046/j.1365-2168.1998.00795.x. PMID 9717995
- RESULTSmyrniotis V, Farantos C, Kostopanagiotou G, Arkadopoulos N. Vascular control during hepatectomy: review of methods and results. World J Surg. 2005 Nov;29(11):1384-96. doi: 10.1007/s00268-005-0025-x. PMID 16222453
- RESULTIshizaki Y, Yoshimoto J, Miwa K, Sugo H, Kawasaki S. Safety of prolonged intermittent pringle maneuver during hepatic resection. Arch Surg. 2006 Jul;141(7):649-53; discussion 654. doi: 10.1001/archsurg.141.7.649. PMID 16847234
- RESULTAlkozai EM, Lisman T, Porte RJ. Bleeding in liver surgery: prevention and treatment. Clin Liver Dis. 2009 Feb;13(1):145-154. doi: 10.1016/j.cld.2008.09.012.