Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection
Primary Purpose
Liver Disease
Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Preoperative Gabexate Mesilate group
Intraoperative Gabexate Mesilate group
hepatectomy with dextrose water
Sponsored by

About this trial
This is an interventional supportive care trial for Liver Disease focused on measuring Synthetic Protease Inhibitor, Hepatectomy, Postoperative Complications
Eligibility Criteria
Inclusion Criteria:
- All liver tumors that require resection of more than two segments of the liver.
- Age ≥20 and ≤80
- General performance status: the Karnofsky score> 70% or ECOG 0-1
Exclusion Criteria:
- Hepatic duct reconstruction was performed
- ASA (American society of anesthesiologists' physical status classification) score: ≥3
- Patients with drug or alcohol addiction
- Patients showing low compliance
- Patients who not want to involve the clinical trial
- Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo group
Preoperative Gabexate Mesilate group
Intraoperative Gabexate Mesilate group
Arm Description
hepatectomy without Gabexate Mesilate
Gabexate Mesilate administered from the preoperative day
Gabexate Mesilate administered from the operative day
Outcomes
Primary Outcome Measures
Postoperative complications
Secondary Outcome Measures
Liver function recovery time
length of hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02710266
Brief Title
Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
This study was closed earlier than planned because targeted participant recruitment is not smooth.
Study Start Date
February 24, 2012 (Actual)
Primary Completion Date
February 25, 2017 (Actual)
Study Completion Date
February 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Liver resection have been a primary treatment option for lesions found in the liver. With improvements in surgical technique and perioperative patient management, morbidity and mortality related to liver resection have been greatly reduced. However, many patients with hepatocellular carcinoma have underlying liver disease. Severity of underlying liver disease plays an important role in decision making of resection extent. Therefore, liver failure and decreased liver function following liver resection still remains to be an critical issue.
Postresection liver failure is generally defined by serum total bilirubin greater than 3mg/dL and prothrombin time of less than 50% of normal (INR >1.7). Pathophysiology of postresection liver failure is not yet well known. However, sepsis after liver resection, small-for-size syndrome (SFSS), and ischemia/reperfusion injury are known to have important roles in persistant liver injury after resection.
After a liver resection, kupffer cells are drastically decreased and innate immunity of the patient is also damaged. This process causes the patient to be vulnerable to infection. In addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered and liver regeneration is affected.
Complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute inflammatory cytokines.
Recent studies have reported on many promising effects of the synthetic protease inhibitor, such as Gabexate mesilate. These include antioxidant effect, inhibition of acute inflammatory cytokine reaction, and anticoagulatory property. Based on these effects, synthetic protease inhibitor have gained attention in the role of hepatocyte protection after liver resection.
Currently, there is a report on the hepatocyte protective effects of Gabexate Mesilate on ischemia/reperfusion injury caused by the Pringle maneuver. However, with the advances in surgical technique and equipment, many surgeons now perform liver resection without Pringle maneuver. Therefore, this study was designed to determine effects of Gabexate Mesilate in the liver resection performed without Pringle maneuver.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
Synthetic Protease Inhibitor, Hepatectomy, Postoperative Complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
hepatectomy without Gabexate Mesilate
Arm Title
Preoperative Gabexate Mesilate group
Arm Type
Experimental
Arm Description
Gabexate Mesilate administered from the preoperative day
Arm Title
Intraoperative Gabexate Mesilate group
Arm Type
Experimental
Arm Description
Gabexate Mesilate administered from the operative day
Intervention Type
Drug
Intervention Name(s)
Preoperative Gabexate Mesilate group
Intervention Description
Gabexate Mesilate is administered from the preoperative day and continued for 5 days. 300mg of Gabexate Mesilate is mixed with 500cc of 5% dextrose water and administered at 40cc/hr for 12 hours each day.
Intervention Type
Drug
Intervention Name(s)
Intraoperative Gabexate Mesilate group
Intervention Description
Gabexate Mesilate is administered from the operative day and continued for 5 days. 300mg of Gabexate Mesilate is mixed with 500cc of 5% dextrose water and administered at 40cc/hr for 12 hours each day.
Intervention Type
Drug
Intervention Name(s)
hepatectomy with dextrose water
Intervention Description
Gabexate Mesilate is not administered. As placebo, 500cc of 5% dextrose water is administered at 40cc/hr for 12 hours
Primary Outcome Measure Information:
Title
Postoperative complications
Time Frame
Within the first 30 days after surgery
Secondary Outcome Measure Information:
Title
Liver function recovery time
Time Frame
4 weeks
Title
length of hospitalization
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All liver tumors that require resection of more than two segments of the liver.
Age ≥20 and ≤80
General performance status: the Karnofsky score> 70% or ECOG 0-1
Exclusion Criteria:
Hepatic duct reconstruction was performed
ASA (American society of anesthesiologists' physical status classification) score: ≥3
Patients with drug or alcohol addiction
Patients showing low compliance
Patients who not want to involve the clinical trial
Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18251159
Citation
Kim YI, Fujita S, Hwang YJ, Chun JM, Song KE, Chun BY. Successful intermittent application of the Pringle maneuver for 30 minutes during human hepatectomy: a clinical randomized study with use of a protease inhibitor. Hepatogastroenterology. 2007 Oct-Nov;54(79):2055-60.
Results Reference
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Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection
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