Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-01 @ 6:05 AM
Study NCT ID:
NCT02710266
Status:
TERMINATED
Last Update Posted:
2018-07-18
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'This study was closed earlier than planned because targeted participant recruitment is not smooth.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-15', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'Within the first 30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Liver function recovery time', 'timeFrame': '4 weeks'}, {'measure': 'length of hospitalization', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Synthetic Protease Inhibitor', 'Hepatectomy', 'Postoperative Complications'], 'conditions': ['Liver Disease']}, 'referencesModule': {'references': [{'pmid': '18251159', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPostresection 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.\n\nAfter 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.\n\nComplex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute inflammatory cytokines.\n\nRecent 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.\n\nCurrently, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All liver tumors that require resection of more than two segments of the liver.\n* Age ≥20 and ≤80\n* General performance status: the Karnofsky score\\> 70% or ECOG 0-1\n\nExclusion Criteria:\n\n* Hepatic duct reconstruction was performed\n* ASA (American society of anesthesiologists' physical status classification) score: ≥3\n* Patients with drug or alcohol addiction\n* Patients showing low compliance\n* Patients who not want to involve the clinical trial\n* Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)"}, 'identificationModule': {'nctId': 'NCT02710266', 'briefTitle': 'Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2011-0936'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'hepatectomy without Gabexate Mesilate', 'interventionNames': ['Drug: hepatectomy with dextrose water']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative Gabexate Mesilate group', 'description': 'Gabexate Mesilate administered from the preoperative day', 'interventionNames': ['Drug: Preoperative Gabexate Mesilate group']}, {'type': 'EXPERIMENTAL', 'label': 'Intraoperative Gabexate Mesilate group', 'description': 'Gabexate Mesilate administered from the operative day', 'interventionNames': ['Drug: Intraoperative Gabexate Mesilate group']}], 'interventions': [{'name': 'Preoperative Gabexate Mesilate group', 'type': 'DRUG', '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.', 'armGroupLabels': ['Preoperative Gabexate Mesilate group']}, {'name': 'Intraoperative Gabexate Mesilate group', 'type': 'DRUG', '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.', 'armGroupLabels': ['Intraoperative Gabexate Mesilate group']}, {'name': 'hepatectomy with dextrose water', 'type': 'DRUG', 'description': 'Gabexate Mesilate is not administered. As placebo, 500cc of 5% dextrose water is administered at 40cc/hr for 12 hours', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}