Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
Study NCT ID:
NCT00885950
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2009-04-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006504', 'term': 'Hepatic Veno-Occlusive Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Paraffin embedded liver tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-03', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histologically proven hepatic sinusoidal injury', 'timeFrame': 'during liver surgery'}], 'secondaryOutcomes': [{'measure': '90-day morbidity and mortality', 'timeFrame': 'up until 90 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal liver metastases', 'neoadjuvant chemotherapy', 'oxaliplatin', 'sinusoidal obstruction syndrome', 'anticoagulants'], 'conditions': ['Sinusoidal Obstruction Syndrome', 'Colorectal Liver Metastases']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether anticoagulant use (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant chemotherapy in patients suffering from colorectal liver metastases.', 'detailedDescription': 'Surgical resection remains the only curative treatment for patients suffering from colorectal liver metastases, but only 15-25% of patients are initially eligible for resection. The majority of patients suffering from colorectal liver metastases receives chemotherapy prior to liver surgery in order to downsize the colorectal liver metastases. Preoperative treatment with oxaliplatin-based chemotherapy is related to sinusoidal injury, the so-called sinusoidal obstruction syndrome. Patients with histologically proven sinusoidal injury undergoing liver surgery have a higher risk of post-resectional morbidity. Damage to the hepatic sinusoids is a key factor for the development of the sinusoidal obstruction syndrome. Anticoagulants (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) might be able to prevent this damage and, consequently, the development of the sinusoidal obstruction syndrome in patients suffering from colorectal liver metastases treated with neoadjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from colorectal liver metastases who have undergone a partial hepatic resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* colorectal liver metastases that are eligible for resection\n* operated from January 2008 up until December 2009 at Maastricht University Medical Centre\n\nExclusion Criteria:\n\n* irresectable colorectal liver metastases'}, 'identificationModule': {'nctId': 'NCT00885950', 'briefTitle': 'Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Prevention of the Hepatic Sinusoidal Obstruction Syndrome Secondary to Oxaliplatin-based Neoadjuvant Chemotherapy for Colorectal Liver Metastases by Means of Anticoagulants', 'orgStudyIdInfo': {'id': '08-4-076'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal liver metastases', 'description': 'Patients with colorectal liver metastases undergoing partial hepatic resection who were preoperatively treated with either neoadjuvant chemotherapy or not and/or anticoagulants or not'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Department of Surgery; Maastricht University Medical Centre', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Steven WM Olde Damink, MD, PhD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Centre'}, {'name': 'Rob Jansen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}