Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-20 @ 8:24 AM
Study NCT ID:
NCT07284004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatty Liver in Long Standing Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-11-30', 'studyFirstSubmitQcDate': '2025-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of metabolic dysfunction-associated fatty liver disease (MAFLD) in patients after long term follow up post cholecystectomy', 'timeFrame': '5 years post-cholecystectomy'}], 'secondaryOutcomes': [{'measure': 'Changes in serum level of ALT in post-cholecystectomy patients', 'timeFrame': 'Annually for 5 years'}]}, 'conditionsModule': {'conditions': ['Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic Steatosis']}, 'descriptionModule': {'briefSummary': 'This observational study aims to evaluate the association between long-term cholecystectomy and the development of metabolic dysfunction-associated fatty liver disease (MAFLD) in adult patients. The study will assess the prevalence and severity of hepatic steatosis in individuals who underwent cholecystectomy several years earlier and compare clinical, metabolic, and biochemical parameters to identify potential risk factors. The goal is to determine whether cholecystectomy contributes to metabolic alterations that increase the likelihood of MAFLD in the long term.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥18 years) who have undergone cholecystectomy at least 5 years prior to enrollment, with no known chronic liver diseases other than metabolic dysfunction-associated fatty liver disease (MAFLD). Participants will be recruited from outpatient gastroenterology clinics and will provide informed consent before enrollment. Both male and female patients will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n1. Patients less than 18 years old.\n2. Body mass index (BMI) ≤ 25 kg/m2\n3. Patients with chronic renal failure.\n4. Patients with liver cirrhosis.\n5. Patients with acute liver dysfunction.\n6. Breast feeding and pregnancy.\n7. patients have done cholecystectomy less than 5 years ago.'}, 'identificationModule': {'nctId': 'NCT07284004', 'acronym': 'MAFLD-Chole St', 'briefTitle': 'Fatty Liver in Long Standing Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patiens', 'orgStudyIdInfo': {'id': 'Soh-Med--25-11-6MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long-term cholecystectomy patients'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yasmeen Ahmed Farrag', 'role': 'CONTACT', 'email': 'yasmeen_ahmed_post@med.sohag.edu.eg', 'phone': '201027291125'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yasmeen Ahmed Farrag Ahmed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor Tropical Medicine and Gastroenterology', 'investigatorFullName': 'Yasmeen Ahmed Farrag Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}