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Trial record 45 of 581 for:    bilirubin AND liver function

Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02710266
Recruitment Status : Terminated (This study was closed earlier than planned because targeted participant recruitment is not smooth.)
First Posted : March 16, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Liver Disease Drug: Preoperative Gabexate Mesilate group Drug: Intraoperative Gabexate Mesilate group Drug: hepatectomy with dextrose water Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Actual Study Start Date : February 24, 2012
Actual Primary Completion Date : February 25, 2017
Actual Study Completion Date : February 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo group
hepatectomy without Gabexate Mesilate
Drug: hepatectomy with dextrose water
Gabexate Mesilate is not administered. As placebo, 500cc of 5% dextrose water is administered at 40cc/hr for 12 hours

Experimental: Preoperative Gabexate Mesilate group
Gabexate Mesilate administered from the preoperative day
Drug: Preoperative Gabexate Mesilate group
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.

Experimental: Intraoperative Gabexate Mesilate group
Gabexate Mesilate administered from the operative day
Drug: Intraoperative Gabexate Mesilate group
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.




Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: Within the first 30 days after surgery ]

Secondary Outcome Measures :
  1. Liver function recovery time [ Time Frame: 4 weeks ]
  2. length of hospitalization [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710266


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02710266     History of Changes
Other Study ID Numbers: 4-2011-0936
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yonsei University:
Synthetic Protease Inhibitor
Hepatectomy
Postoperative Complications

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Gabexate
Anticoagulants
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action