Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT06402305
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid Profile and Ultrasound Findings in Patients with Pancreaticobiliary Diseases', 'timeFrame': '1 year', 'description': '* To evaluate the lipid profile and ultrasound findings in biliary diseases\n* To assess the lipid profile and ultrasound findings in pancreatic diseases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases']}, 'referencesModule': {'references': [{'pmid': '7817971', 'type': 'BACKGROUND', 'citation': 'Attili AF, Carulli N, Roda E, Barbara B, Capocaccia L, Menotti A, Okoliksanyi L, Ricci G, Capocaccia R, Festi D, et al. Epidemiology of gallstone disease in Italy: prevalence data of the Multicenter Italian Study on Cholelithiasis (M.I.COL.). Am J Epidemiol. 1995 Jan 15;141(2):158-65. doi: 10.1093/oxfordjournals.aje.a117403.'}, {'pmid': '27012480', 'type': 'BACKGROUND', 'citation': 'Carr RA, Rejowski BJ, Cote GA, Pitt HA, Zyromski NJ. Systematic review of hypertriglyceridemia-induced acute pancreatitis: A more virulent etiology? Pancreatology. 2016 Jul-Aug;16(4):469-76. doi: 10.1016/j.pan.2016.02.011. Epub 2016 Mar 3.'}, {'pmid': '29409760', 'type': 'BACKGROUND', 'citation': 'Crockett SD, Wani S, Gardner TB, Falck-Ytter Y, Barkun AN; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on Initial Management of Acute Pancreatitis. Gastroenterology. 2018 Mar;154(4):1096-1101. doi: 10.1053/j.gastro.2018.01.032. Epub 2018 Feb 3. No abstract available.'}, {'pmid': '19847878', 'type': 'BACKGROUND', 'citation': 'Halldestam I, Kullman E, Borch K. Incidence of and potential risk factors for gallstone disease in a general population sample. Br J Surg. 2009 Nov;96(11):1315-22. doi: 10.1002/bjs.6687.'}]}, 'descriptionModule': {'briefSummary': "Gall stones happen is the most prevalent pathology affecting the biliary system due to its Physiological function of concentration of bile having a prevalence of 10%-15% and an incidence of 1.4% per year in the adult population of developed countries (Halldestam et al,. 2009). Women are more commonly affected by gall stone disease as compared to men (Attili et al,. 1995).\n\nMultiple risk factors responsible for the Gall stone formation include modifiable factors such as lifestyle factors (reduced physical activity, rapid weight loss, fasting, and oral contraceptives (Di Ciaula et al,. 2013); dietary factors (high fat, high cholesterol, high refined carbohydrates, and low fiber ; metabolic syndrome (obesity, diabetes mellitus, dyslipidemia, and hyperinsulinemia (Cuevas et al., 2004).\n\nAmong all the above mentioned risk factors, serum lipids are considered to be the most important risk factor involved in the pathogenesis of Gall stone disease (Celika et al,. 2015). Hyperlipidemia is generally characterized by high serum levels of total cholesterol, triglycerides, low density lipoproteins (LDL-C), and low levels of high-density lipoprotein (HDL-C). Some studies have showed a significant association of hyperlipidemia with gall stones especially hypertriglyceridemia and increased LDL-C levels (Rao et al,. 2012).\n\nAcute pancreatitis (AP) is an inflammatory condition of the pancreas that originates within the pancreatic acinar cells and causes pancreatic necrosis, systemic inflammatory response syndrome, and multiple organ failure (Crockett et al,. 2013). According to The revised Atlanta classification system from 2012 ,AP is diagnosed on the basis of two of three criteria-typically belt-like abdominal pain, an elevated serum lipase level three times above the normal threshold, and radiological imaging signs of pancreatitis (Parniczky et al,.2016).\n\nSevere hypertriglyceridemia is a well-known cause of AP. Recent studies have suggested that elevated serum triglyceride and low high-density lipoprotein cholesterol (HDL-C) levels are associated with persistent organ failure in acute pancreatitis (Peng et al,. 2015). With the change of people's diet structure and lifestyle, the incidence and mortality of hypertriglyceridemic AP are increasing year by year and has surpassed alcohol as the second leading cause of AP (Carr et al,. 2016).\n\nChronic pancreatitis is a syndrome characterized by chronic progressive pancreatic inflammation, fibrosis, and scarring, resulting in damage to and loss of exocrine (acinar), endocrine (islet cells), and ductal cells(Majumder S,. 2016)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with adiagnosis of gall stones ,acute calcular cholecystitis,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age above 18 years\n* Patients with confirmed diagnosis of gall stones ,acute calcular cholecystitis ,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis\n\nExclusion Criteria:\n\n* Patients with renal failure, hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film).\n* Patients on antihyperlipidemic drugs .'}, 'identificationModule': {'nctId': 'NCT06402305', 'briefTitle': 'Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases', 'orgStudyIdInfo': {'id': 'Soh-Med-24-04-015MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': 'Cases', 'interventionNames': ['Diagnostic Test: Lipid profile']}, {'label': 'group B', 'description': 'Controls', 'interventionNames': ['Diagnostic Test: Lipid profile']}], 'interventions': [{'name': 'Lipid profile', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Abdominal ultrasound'], 'description': 'Abdominal ultrasound and lipid profile will be done', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Alaa M Mostafa, Resident', 'role': 'CONTACT', 'email': 'Alaa.Mohamed2015m@med.sohag.edu.eg', 'phone': '01099143258'}, {'name': 'Asmaa N Mohammed, Professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaa Mohamed Mostafa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident in Tropical Medicine and Gastroenterology Department Sohag University Hospital', 'investigatorFullName': 'Alaa Mohamed Mostafa', 'investigatorAffiliation': 'Sohag University'}}}}