Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT04705961
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report
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': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2021-01-09', 'studyFirstSubmitQcDate': '2021-01-09', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrent hydatid cyst', 'timeFrame': '2 or 3 month', 'description': 'presence of recurrent hydatid cyst'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydatidosis', 'complications', 'intra-biliary rupture', 'biliary duct', 'echinococcus', 'echinococcosis'], 'conditions': ['Surgery--Complications']}, 'descriptionModule': {'briefSummary': 'In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.', 'detailedDescription': 'In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.\n\nHere, a bile leakage test performed in a 23-year-old male patient undergoing emergency surgery due to the perforation of the hydatid liver cyst was presented. Following the treatment of perforated hydatid liver cyst and biliary peritonitis, a bile leakage test was performed. The common bile duct was cannulated with a 22 Gauge catheter, normal saline and parenteral lipid solution were given to demonstrate the CBCs, and leakage areas were suture ligated. The patient was discharged postoperatively without any problem.\n\nThe investigators recommend detection and treatment of the CBCs even in emergency hydatid liver cyst surgery for prevention of postoperative biliary complications.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'this study is a case report', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* this study is a case report\n\nExclusion Criteria:\n\n* this study is a case report'}, 'identificationModule': {'nctId': 'NCT04705961', 'briefTitle': 'Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Ersin Arslan Education and Training Hospital'}, 'officialTitle': 'Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report', 'orgStudyIdInfo': {'id': '10012021'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Ersin Arslan Training and Resource Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Ersin Arslan Education and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ufuk Uylas', 'investigatorAffiliation': 'Dr. Ersin Arslan Education and Training Hospital'}}}}