Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-01 @ 4:41 AM
Study NCT ID:
NCT06960733
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Winged Versus Traditional Plastic Stents for Biliary Drainage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysfunction', 'timeFrame': '3 Months', 'description': 'Sign of dysfunction of biliary stenting (fever, pain, jaundice)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'Biliary obstruction', 'biliary stenting', 'plastic stent'], 'conditions': ['Biliary Obstruction', 'Bile Duct Stones', 'Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': 'This study was randomized, controlled, blinded trial with a two-arm parallel-group design to directly compare the therapeutic outcomes of winged versus conventional stents in patients with benign or malignant biliopancreatic conditions requiring ERCP and subsequent insertion or replacement of plastic stents.', 'detailedDescription': 'Procedure The study was structured as a randomized, controlled trial using a two-arm parallel group design to compare different therapies (winged stent vs. conventional stent). Randomization was carried out in a 1:1 ratio using block randomization. Upon stent exchange, participants were switched to the alternate treatment group. Each subject was intended to receive both forms of therapy over the course of the treatment periods in a crossover design, with only the sequence of therapies being determined randomly (Figure 1).\n\nThe procedures were conducted using standard techniques. No additional steps, biopsies, or similar procedures were required. For the ERCPs carried out in the Endoscopy Department of the University Hospital Leipzig, Fujifilm video duodenoscopes were utilized\n\nData On the procedure date, we gathered essential baseline and procedural information including demographic data (age and gender), previous stent interventions, diagnostic imaging and laboratory results, specifics of the stent used (type, diameter, and length), the effectiveness of the stent insertion, and any associated complications.\n\nBeyond standard care, follow-up was conducted at intervals of one week, one month, and two months post-intervention, utilizing a methodical questionnaire to monitor clinical progress and evaluate for any stent-related dysfunction."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biliopancreatic disorder requiring plaxtic biliary stent therapy\n* written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Live Expectancy of less than one month\n* Biliary drainage by metal stent or external drainage.'}, 'identificationModule': {'nctId': 'NCT06960733', 'briefTitle': 'Comparison Between Winged Versus Traditional Plastic Stents for Biliary Drainage', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Comparative Efficacy of Winged Versus Traditional Plastic Stents for Biliary Drainage in Benign and Malignant Obstructions: A Randomized Study', 'orgStudyIdInfo': {'id': 'Viaduct-ERCP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Stenting', 'description': 'Stenting of biliary tract by standard plastic stent. Change of stent-type at regular stent exchange after three months (from winged to standard and vice versae).', 'interventionNames': ['Device: Winged plastic stent', 'Device: Standard plastic stents']}, {'type': 'EXPERIMENTAL', 'label': 'Winged Stent', 'description': 'Stenting of biliary tract by use of winged-design stent. Change of stent-type at regular stent exchange after three months (from winged to standard and vice versae).', 'interventionNames': ['Device: Winged plastic stent', 'Device: Standard plastic stents']}], 'interventions': [{'name': 'Winged plastic stent', 'type': 'DEVICE', 'description': 'Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention winged stents were used.', 'armGroupLabels': ['Conventional Stenting', 'Winged Stent']}, {'name': 'Standard plastic stents', 'type': 'DEVICE', 'description': 'Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention standard plastic stents were used.', 'armGroupLabels': ['Conventional Stenting', 'Winged Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'University of Leipzig Medical Center, Department of Gastroenterology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Albrecht Hoffmeister, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Leipzig Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}