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.
Condition or disease | Intervention/treatment | Phase |
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Hepatectomy Cancer, Metastatic Hemostasis | Device: Hemopatch Procedure: Common Surgical Techniques | Not Applicable |
Advances in surgical techniques have reduced the occurrence of postoperative complications following liver resection and resulted in low surgical mortality and morbidity rates in high-volume centers.
Although partial liver resections for primary or secondary hepatic malignancies are considered standard interventions, intraoperative blood loss remains a risk factor associated with major complications in liver surgery [1-3]. There are several methods for reduction of blood loss, including meticulous resection technique along anatomical planes, reduction of central venous pressure during transection of the liver parenchyma [4], and vascular occlusion techniques (i.e., inflow occlusion and total vascular occlusion) [5-7]. In addition, specific instruments were devised for liver transection, such as the ultrasonic dissector, water jet, and other, more recent developments (e.g., focal radiofrequency ablation) that allow sealing of small vessels during transection [8, 9].
In order to control diffuse bleeding and to prevent intraperitoneal complications attributed to bleeding, various topical products are used when the conventional methods, such as suture, ligation, or argon beam coagulation, fail. Currently, there are numerous products on the market which are promising a successful outcome for hemostasis. These products include gelatin, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | March 17, 2017 |
Estimated Primary Completion Date : | November 17, 2018 |
Estimated Study Completion Date : | March 17, 2019 |
Arm | Intervention/treatment |
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Experimental: Hemopatch 45x90 mm - CE 0297 Class III
Hemopatch + Common surgical techniques
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Device: Hemopatch
Hemopatch is applied upon the verification made by the surgeon of the presence of an appropriate target bleeding site in the hepatic parenchyma. At the time point of application a stopwatch starts simultaneously. Time to hemostasis is defined as the time required to obtain successful haemostasis in a single bleeding site. At 3 minutes the inspection will be made and, if haemostasis is not achieved, the treatment is considered failed and the Principal Investigator and/or his delegates is allowed to use additional haemostatic measures.The time to haemostasis will be recorded in the patient's medical record and in the electronic Case Report Form. The bleeding site will be observed for 1 additional minute at the end of the haemostatic procedure and, of the surgery to confirm the haemostasis.
Other Names:
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Standard Surgery Technique
Common surgical techniques
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Procedure: Common Surgical Techniques
Patients undergoing liver resection for any underlying disease and with resectable mass. The list of the underlying diseases is the following (but might not be limited to): 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.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pacelli | 00390630155133 ext 4477 | fabio.pacelli@policlinicogemelli.it |
Italy | |
Policlinico Universitario Agostino Gemelli | Recruiting |
Rome, Italy, 00168 | |
Contact: Pacelli 00390630155133 ext 4477 fabio.pacelli@policlinicogemelli.it | |
Principal Investigator: Fabio FP Pacelli, MD |
Principal Investigator: | Fabio FP Pacelli, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Tracking Information | |||||
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First Submitted Date ICMJE | October 5, 2017 | ||||
First Posted Date ICMJE | October 27, 2017 | ||||
Last Update Posted Date | November 8, 2017 | ||||
Actual Study Start Date ICMJE | March 17, 2017 | ||||
Estimated Primary Completion Date | November 17, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Evaluated comparing the achievement of hemostasis within 3 minutes from the application of the patch [ Time Frame: Day 0 - T3 (Surgery) ] Evaluation of the improvement of the time of hemostasis
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Original Primary Outcome Measures ICMJE |
Evaluated comparing the achievement of hemostasis within 3 minutes from the application of the patch [ Time Frame: Day 0 - T3 (Surgery) ] To explore whether Hemopatch can improve time to hemostasis
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Tolerability of Hemopatch After Hepatic Resection | ||||
Official Title ICMJE | 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 | ||||
Brief Summary |
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. |
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Detailed Description |
Advances in surgical techniques have reduced the occurrence of postoperative complications following liver resection and resulted in low surgical mortality and morbidity rates in high-volume centers. Although partial liver resections for primary or secondary hepatic malignancies are considered standard interventions, intraoperative blood loss remains a risk factor associated with major complications in liver surgery [1-3]. There are several methods for reduction of blood loss, including meticulous resection technique along anatomical planes, reduction of central venous pressure during transection of the liver parenchyma [4], and vascular occlusion techniques (i.e., inflow occlusion and total vascular occlusion) [5-7]. In addition, specific instruments were devised for liver transection, such as the ultrasonic dissector, water jet, and other, more recent developments (e.g., focal radiofrequency ablation) that allow sealing of small vessels during transection [8, 9]. In order to control diffuse bleeding and to prevent intraperitoneal complications attributed to bleeding, various topical products are used when the conventional methods, such as suture, ligation, or argon beam coagulation, fail. Currently, there are numerous products on the market which are promising a successful outcome for hemostasis. These products include gelatin, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
98 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 17, 2019 | ||||
Estimated Primary Completion Date | November 17, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Italy | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03323359 | ||||
Other Study ID Numbers ICMJE | PAC-HEM-16-001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ||||
Study Sponsor ICMJE | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ||||
Collaborators ICMJE | Baxter Healthcare Corporation | ||||
Investigators ICMJE |
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PRS Account | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ||||
Verification Date | October 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |