Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT03456557
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003570', 'term': 'Cytidine Triphosphate'}], 'ancestors': [{'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-10', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relation between CT perfusion calculated k-trans and clinicobiological SIRS score in early phase of acute pancreatitis.', 'timeFrame': 'admission day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The investigators to establish whether early microvascular permeability parameter evaluated by perfusion-CT could be good biomarkers for severity in acute pancreatitis.\n\nTherefore the investigators want to compare 48 hours-clinico-biological systemic inflammatory response syndrome score to initial microvascular permeability parameters ( ktrans - capillary membrane permeability factor- and pancreatic blood flow ) calculated by OLEA software using inclusion perfusion CT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with acute pancreatitis (based on the Atlanta definition).\n\nExclusion Criteria:\n\n* Patient under 18 yearras old\n* Contraindication of injection of iodinated contrast medium\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03456557', 'acronym': 'K-PA', 'briefTitle': 'The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score', 'orgStudyIdInfo': {'id': 'K-PA Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computed tomography.', 'interventionNames': ['Radiation: Perfusion computed tomography.']}], 'interventions': [{'name': 'Perfusion computed tomography.', 'type': 'RADIATION', 'description': 'Using specific post treatment imaging software ( Olea® ) we will calculatell permeability parameters : the pancreatic blood flow and the k-trans, capillary membrane permeability factor.', 'armGroupLabels': ['Computed tomography.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Chu de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}