Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-28 @ 8:38 AM
Study NCT ID:
NCT02460432
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-07-24', 'unreleaseDateUnknown': True}, {'resetDate': '2017-12-18', 'releaseDate': '2017-07-25'}, {'resetDate': '2019-02-12', 'releaseDate': '2018-09-19'}, {'resetDate': '2019-05-10', 'releaseDate': '2019-02-12'}, {'resetDate': '2024-01-11', 'releaseDate': '2023-04-11'}], 'estimatedResultsFirstSubmitDate': '2017-07-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2015-05-26', 'studyFirstSubmitQcDate': '2015-05-29', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative stent patency during 6months after stent placement', 'timeFrame': '6 month', 'description': 'Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.'}], 'secondaryOutcomes': [{'measure': 'Stent migration', 'timeFrame': '6 month', 'description': 'Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP.'}, {'measure': 'Secondary stent insertion due to recurrent biliary obstruction', 'timeFrame': '6 month'}, {'measure': 'Mean survival', 'timeFrame': '6 month'}, {'measure': 'Adverse events', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug-eluting Biliary stent', 'Covered metalic stent'], 'conditions': ['Biliary Neoplasms', 'Biliary Obstruction', 'Pancreatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '30414164', 'type': 'DERIVED', 'citation': 'Jang SI, Lee KT, Choi JS, Jeong S, Lee DH, Kim YT, Lee SH, Yu JS, Lee DK. Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study. Endoscopy. 2019 Sep;51(9):843-851. doi: 10.1055/a-0754-5763. Epub 2018 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.', 'detailedDescription': 'In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates. Endoscopic retrograde cholangiography (ERCP)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction. The major mechanisms of self-expandable metallic stent (SEMS) occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a drug-eluting stent in order to improve stent patency. Limited data exist regarding outcomes of paclitaxel-eluting stents in malignant biliary obstruction. This study is to prospectively compare the effectiveness and safety of paclitaxel-eluting covered metal stent and covered metal stent for the treatment of malignant biliary obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 19 years of age\n* Malignant mid or distal biliary obstruction\n* Unresectable cancer\n* Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)\n* Patient willing to provide written informed consent and comply with follow-up requirements\n\nExclusion Criteria:\n\n* Patients who had undergone surgical biliary drainage\n* Severe bleeding disorder (e.g. coagulopathy)\n* Polypoid lesion or intra-abdominal abscess\n* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.'}, 'identificationModule': {'nctId': 'NCT02460432', 'briefTitle': 'Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taewoong Medical Co., Ltd.'}, 'officialTitle': 'A Prospective, Randomized, Single Blind Study to Evaluate the Effectiveness and Safety Comparing Niti-S Mira-Cover III Biliary Stent With ComVi Biliary Covered Stent in Patients With Malignant Biliary Obstruction', 'orgStudyIdInfo': {'id': 'MIRA-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel-eluting metal Stent', 'description': 'Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)', 'interventionNames': ['Device: Paclitaxel-eluting metal Stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Covered Metal Stent', 'description': 'ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)', 'interventionNames': ['Device: Covered Metal Stent']}], 'interventions': [{'name': 'Paclitaxel-eluting metal Stent', 'type': 'DEVICE', 'description': 'Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP', 'armGroupLabels': ['Paclitaxel-eluting metal Stent']}, {'name': 'Covered Metal Stent', 'type': 'DEVICE', 'description': 'Insertion of ComVi Biliary Covered Stent using ERCP', 'armGroupLabels': ['Covered Metal Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '633-165', 'city': 'Busan', 'state': 'Bokji-ro Busanjin-gu', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Haehak-ro Jongno-gu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '400-711', 'city': 'Incheon', 'state': 'Inhang-ro Jung-gu', 'country': 'South Korea', 'facility': 'In Ha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '130-710', 'city': 'Seoul', 'state': 'Irwon-Dong, Gangnam-Gu', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong Ki Lee, Ph.D MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gangnam Severance Hospital'}, {'name': 'Kyu Taek Lee, Ph.D MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Sang Hyub Lee, Ph.D MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Don Haeng Lee, Ph.D MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'In Ha University Hospital'}, {'name': 'Jung Sik Choi, Ph.D MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'February 12, 2016'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taewoong Medical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-07-24', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-07-25', 'type': 'RELEASE'}, {'date': '2017-12-18', 'type': 'RESET'}, {'date': '2018-09-19', 'type': 'RELEASE'}, {'date': '2019-02-12', 'type': 'RESET'}, {'date': '2019-02-12', 'type': 'RELEASE'}, {'date': '2019-05-10', 'type': 'RESET'}, {'date': '2023-04-11', 'type': 'RELEASE'}, {'date': '2024-01-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Taewoong Medical Co., Ltd.'}}}}