Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT01869894
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction
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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median patency duration', 'timeFrame': 'Approximately 6 months later since the date of stent insertion', 'description': 'Primary end point : A. Median patency duration'}], 'secondaryOutcomes': [{'measure': '6-months patency rate', 'timeFrame': 'Approximately 6 months later since the date of stent insertion', 'description': 'Secondary end point : A. 6-months patency rate'}]}, 'conditionsModule': {'keywords': ['Malignant biliary obstruction', 'metal stent', 'patency'], 'conditions': ['Malignant Biliary Obstruction']}, 'referencesModule': {'references': [{'pmid': '15082593', 'type': 'RESULT', 'citation': 'Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, Nakai Y, Yamamoto N, Tada M, Yoshida H, Shiratori Y, Kawabe T, Omata M. A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant biliary obstruction. Gut. 2004 May;53(5):729-34. doi: 10.1136/gut.2003.018945.'}, {'pmid': '1281903', 'type': 'RESULT', 'citation': 'Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92. doi: 10.1016/0140-6736(92)92752-2.'}, {'pmid': '27864713', 'type': 'DERIVED', 'citation': 'Lee HJ, Chung MJ, Park JY, Park SW, Nam CM, Song SY, Bang S. A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction. Surg Endosc. 2017 Aug;31(8):3159-3167. doi: 10.1007/s00464-016-5341-8. Epub 2016 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who had malignant biliary obstruction\n\nExclusion Criteria:\n\n* The patients who had resectable biliary malignancy\n* The patients who had hilar obstruction\n* The patients who had duodenal obstruction\n* The patients who had other malignancy which is not related to biliary obstruction\n* The patients who had uncontrolled infection\n* The patients who had poor performance (ECOG =3 or 4)\n* The patients who were not acquired informed consent\n* The patients who had technically difficult structure for ERCP'}, 'identificationModule': {'nctId': 'NCT01869894', 'briefTitle': 'A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'uncovered double bare metallic stent (S&G Biotech.)', 'description': 'uncovered double bare metallic stent', 'interventionNames': ['Procedure: metallic biliary stent insertion (double bare - S&G Biotech.)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'uncovered single bare metallic stent (S&G Biotech.)', 'description': 'uncovered single bare metallic stent', 'interventionNames': ['Procedure: metallic biliary stent insertion (single bare - S&G Biotech.)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'uncovered single bare metallic stent (Taewoong Medical.)', 'description': 'uncovered single bare metallic stent', 'interventionNames': ['Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.)']}], 'interventions': [{'name': 'metallic biliary stent insertion (double bare - S&G Biotech.)', 'type': 'PROCEDURE', 'description': 'The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S\\&G Biotech.) vs. uncovered single bare metallic stent (S\\&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.', 'armGroupLabels': ['uncovered double bare metallic stent (S&G Biotech.)']}, {'name': 'metallic biliary stent insertion (single bare - S&G Biotech.)', 'type': 'PROCEDURE', 'description': 'The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S\\&G Biotech.) vs. uncovered single bare metallic stent (S\\&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.', 'armGroupLabels': ['uncovered single bare metallic stent (S&G Biotech.)']}, {'name': 'metallic biliary stent insertion (single bare - Taewoong Medical.)', 'type': 'PROCEDURE', 'description': 'The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S\\&G Biotech.) vs. uncovered single bare metallic stent (S\\&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.', 'armGroupLabels': ['uncovered single bare metallic stent (Taewoong Medical.)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}