Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06653205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-22
First Post:
2024-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Acute Pancreatitis Outcome
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-10-20', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality and severity of acute pancreatitis', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute pancreatitis', 'Outcome'], 'conditions': ['Acute', 'Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '35855674', 'type': 'BACKGROUND', 'citation': 'Biyik M, Biyik Z, Asil M, Keskin M. Systemic Inflammation Response Index and Systemic Immune Inflammation Index Are Associated with Clinical Outcomes in Patients with Acute Pancreatitis? J Invest Surg. 2022 Aug;35(8):1613-1620. doi: 10.1080/08941939.2022.2084187. Epub 2022 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'Aim of study prediction of acute pancreatitis outcome by using cheap and available laboratory resources', 'detailedDescription': 'Acute pancreatitis (AP) is a sudden inflammation of the pancreas that can vary from mild, self-resolving episodes to severe, potentially fatal conditions(1). Clinically, AP is classified into mild acute pancreatitis and severe acute pancreatitis (SAP), and SAP patients are described by multi-organ failure and high mortality rates(2). The mortality rate of acute pancreatitis varies, ranging from 3% in cases of mild edematous pancreatitis to as high as 20% in patients with pancreatic necrosis(3).The progression of AP can lead to systemic complications, making early prediction of clinical outcomes essential for effective management(4).\n\nIn recent years, there has been growing interest in identifying reliable biomarkers that can predict the severity and outcomes of acute pancreatitis(5). Systemic inflammation is a key factor in the pathophysiology of acute pancreatitis, often leading to systemic inflammatory response syndrome (SIRS) and subsequent organ dysfunction(6). Consequently, assessing systemic inflammation has become a crucial aspect of managing AP patients(7).\n\nThe Systemic Inflammation Response Index (SIRI) is recognized in the literature as an inflammatory marker that combines routine blood parameters, such as neutrophils, monocytes, and lymphocytes(8). Both SIRI and the Systemic Immune Inflammation Index (SII) are emerging as novel biomarkers for systemic inflammation(9). SIRI is calculated using neutrophil, monocyte, and lymphocyte counts, while SII is based on platelet, neutrophil, and lymphocyte counts(10)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient complaint of abdominal pain ,more than 18 years old,not known to have liver ,renal or malignant disease, typical abdominal ultrasound and computed tomography with findings of acute pancreatitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients age \\>18 years old Serum amylase \\>3 times the upper limit of normal. abdominal pain consistent with acute pancreatitis. Typical abdominal ultrasonography and tomography findings in the routine imaging of the patients were accepted as acute pancreatitis.\n\nPatient complaint of abdominal pain -\n\nExclusion Criteria:\n\nliver diseases patients renal diseases patients malignancy patients\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06653205', 'briefTitle': 'Prediction of Acute Pancreatitis Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Systemic Inflammation Response Index and Systemic Immune Inflammation Index and Prediction of Clinical Outcome in Acute Pancreatitis', 'orgStudyIdInfo': {'id': 'Acute pancreatitis outcome'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mina Ayman Wahba, Resident physician', 'role': 'CONTACT', 'email': 'Mena.16266257@med.aun.edu.eg', 'phone': '+2001208790328'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mina Ayman Wahba', 'investigatorAffiliation': 'Assiut University'}}}}