Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT05113550
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Hepatic Hydatidosis in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004443', 'term': 'Echinococcosis'}], 'ancestors': [{'id': 'D002590', 'term': 'Cestode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '90 days', 'description': 'Patients with postoperative morbidity according to the Clavien-Dindo score 19, "severe complication" (Clavien-Dindo ≥ IIIa) and postoperative mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Echinococcosis']}, 'referencesModule': {'references': [{'pmid': '27729953', 'type': 'BACKGROUND', 'citation': 'Mihmanli M, Idiz UO, Kaya C, Demir U, Bostanci O, Omeroglu S, Bozkurt E. Current status of diagnosis and treatment of hepatic echinococcosis. World J Hepatol. 2016 Oct 8;8(28):1169-1181. doi: 10.4254/wjh.v8.i28.1169.'}, {'pmid': '16400708', 'type': 'BACKGROUND', 'citation': 'Adamina M, Guller U, Weber WP, Oertli D. Propensity scores and the surgeon. Br J Surg. 2006 Apr;93(4):389-94. doi: 10.1002/bjs.5265.'}, {'pmid': '30809783', 'type': 'BACKGROUND', 'citation': 'Jaen-Torrejimeno I, Lopez-Guerra D, Prada-Villaverde A, Blanco-Fernandez G. Pattern of Relapse in Hepatic Hydatidosis: Analysis of 238 Cases in a Single Hospital. J Gastrointest Surg. 2020 Feb;24(2):361-367. doi: 10.1007/s11605-019-04163-7. Epub 2019 Feb 26.'}, {'pmid': '33389115', 'type': 'BACKGROUND', 'citation': 'Jaen-Torrejimeno I, Latorre-Fragua R, Lopez-Guerra D, Rojas-Holguin A, Manuel-Vazquez A, Blanco-Fernandez G, Ramia JM. Jaundice as a clinical presentation in liver hydatidosis increases the risk of postoperative biliary fistula. Langenbecks Arch Surg. 2021 Jun;406(4):1139-1147. doi: 10.1007/s00423-020-02070-z. Epub 2021 Jan 2.'}, {'pmid': '26834196', 'type': 'RESULT', 'citation': 'Muhtarov M, Rainova I, Tamarozzi F. Treatment of Hepatic Cystic Echinococcosis in Patients from the Southeastern Rhodope Region of Bulgaria in 2004-2013: Comparison of Current Practices with Expert Recommendations. Am J Trop Med Hyg. 2016 Apr;94(4):900-5. doi: 10.4269/ajtmh.15-0620. Epub 2016 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. The investigators analyzed the postoperative morbidity and mortality rates of elderly patients who underwent surgery at our unit.', 'detailedDescription': 'Retrospective observational study from prospective database focused on liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit. The study period spanned from January 2006 to October 2020. The study was approved by the Research Ethics Committee of our hospital. An informed consent from the patient was not required since the study was retrospective and observational, and entailed no risk. Seventy years of age was the cutoff age to consider patients as elderly.\n\nInclusion criteria of patients: liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, and LHC treated by total or partial pericystectomy.\n\nExclusion criteria of patients: emergency surgery and simple drainage of cyst.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver hydatid cyst (LHC)\n* pathological diagnosis after surgery\n* LHC treated by total or partial pericystectomy\n\nExclusion Criteria:\n\n* emergency surgery and simple drainage of cyst'}, 'identificationModule': {'nctId': 'NCT05113550', 'acronym': 'ELDHIDA', 'briefTitle': 'Surgical Treatment of Hepatic Hydatidosis in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Extremadura'}, 'officialTitle': 'Surgical Treatment of Hepatic Hydatidosis in Elderly Patients', 'orgStudyIdInfo': {'id': 'HUB-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young group', 'description': 'patients \\< 70 years of age', 'interventionNames': ['Other: Surgical remove']}, {'label': 'Elderly', 'description': 'Patients ≥ 70 years of age)', 'interventionNames': ['Other: Surgical remove']}], 'interventions': [{'name': 'Surgical remove', 'type': 'OTHER', 'description': 'liver hydatid cyst (LHC) treated by total or partial pericystectomy', 'armGroupLabels': ['Elderly', 'Young group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Universidad de Extremadura- Facultad de Medicina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Gerardo Blanco-Fernández', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}], 'overallOfficials': [{'name': 'Gerardo Blanco-Fernández, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Extremadura'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Extremadura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesor', 'investigatorFullName': 'Gerardo Blanco-Fernández', 'investigatorAffiliation': 'Universidad de Extremadura'}}}}