Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04709718
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2021-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Management of Giant Hepatic Hemangioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2021-01-01', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patient getting good result after surgery', 'timeFrame': '1 year', 'description': 'patient asymptomatic after surgery or not'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Angioma']}, 'descriptionModule': {'briefSummary': 'Hepatic hemangiomas are the commonest benign mesenchymal lesions of the liver. Most of these lesions are asymptomatic. Giant hepatic hemangiomas (GHH) (\\> 10 cm) are often symptomatic and require surgical intervention. This study aimed to describe the clinical findings, risk factors, diagnostic approach and management of GHH.', 'detailedDescription': 'Hepatic hemangiomas are the most common benign tumors of the liver with the incidence of 0.4 to 20% . They are most often discovered incidentally on imaging studies. Typical hemangiomas usually do not increase in size over time and therefore are unlikely to cause symptoms. Giant hepatic hemangiomas (GHH) are defined as hemangiomas larger than 5 cm . They are usually responsible for overt clinical symptoms and complications consisting, most often, of upper abdominal pain, hemorrhage, biliary compression, or a consumptive coagulopathy that may require prompt surgical intervention or other treatments . Management of liver hemangiomas ranges from close observation to surgery depending upon the site, size and symptoms .\n\nIt is widely accepted that intervention is indicated only for symptomatic hemangiomas. Surgical resection is indicated in patients with abdominal complaints or complications, or when diagnosis remains inconclusive. The ideal surgical treatment for GHH is still controversial. Enucleation is the preferred surgical method based on the existing literature. In this study, we report our 17-year experience of clinical management of GHH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with symptomatic geant liver hemangioma', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiological diagnosis of geant liver hamangioma.\n\nExclusion Criteria:\n\n* Radiological diagnosis of liver hemangioma less than 10cm.'}, 'identificationModule': {'nctId': 'NCT04709718', 'briefTitle': 'Surgical Management of Giant Hepatic Hemangioma', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sousse'}, 'officialTitle': 'Surgical Management of Giant Hepatic Hemangioma: a 10-year Single Center Experience', 'orgStudyIdInfo': {'id': 'U23464'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'churgery of geant liver hemangioma', 'interventionNames': ['Procedure: hepatectomy']}], 'interventions': [{'name': 'hepatectomy', 'type': 'PROCEDURE', 'description': 'liver resection taking over the liver hemangioma', 'armGroupLabels': ['churgery of geant liver hemangioma']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'waad farhat, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'university of sousse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sousse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sahloul Hospital of Sousse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'ammar houssem', 'investigatorAffiliation': 'Université de Sousse'}}}}