Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 6:39 AM
Study NCT ID:
NCT01960712
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2013-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2013-09-09', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days of bile leakage from the abdominal cavity', 'timeFrame': 'From intervention until day discharge from hospital'}], 'secondaryOutcomes': [{'measure': 'General complications rates. Postoperative hospital stay', 'timeFrame': 'From intervention until day of discharge from hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bile Leakage']}, 'descriptionModule': {'briefSummary': 'Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.', 'detailedDescription': 'All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver resection including at least two liver segments.\n\nExclusion Criteria:\n\n* Hepatobiliary digestive anastomosis.'}, 'identificationModule': {'nctId': 'NCT01960712', 'briefTitle': 'The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.', 'orgStudyIdInfo': {'id': '2006/1142-31/3'}, 'secondaryIdInfos': [{'id': '2006/1142-31/3', 'type': 'OTHER', 'domain': '2006/1142-31/3'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Continued external drainage', 'description': 'Continued external drainage alone.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continued external drainage + transpapillary stent', 'description': 'External drainage + transpapillary plastic stent (7-10 Fr).', 'interventionNames': ['Device: Transpapillary plastic stent (7-10 Fr)']}], 'interventions': [{'name': 'Transpapillary plastic stent (7-10 Fr)', 'type': 'DEVICE', 'description': 'Duodenoscopy plus transpapillary bile cannulation plus stent insertion.', 'armGroupLabels': ['Continued external drainage + transpapillary stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Lars Lundell, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jansson, Anders, M.D.', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lars Lundell', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}