Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT01047332
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2010-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcarrlocke@chpnet.org', 'title': 'Dr. David L. Carr-Locke, MD, FRCP', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From time of stent placement to participant death or lost to follow-up (up to 1302 days).', 'eventGroups': [{'id': 'EG000', 'title': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).', 'otherNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).', 'otherNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'seriousNumAffected': 42}], 'seriousEvents': [{'term': 'Recurrent biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 34}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Stent migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Line infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Gastric outlet obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Radiation gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Whipple resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Cholangitis without biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Change in mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Spinal surgery for cervical stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Pulmonary embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Urinary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Kidney stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Recurrent Biliary Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).'}, {'id': 'OG001', 'title': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).'}], 'classes': [{'categories': [{'measurements': [{'value': '711', 'comment': 'Unable to calculate upper confidence interval because the largest value in the Kaplan-Meier analysis of time to recurrent biliary obstruction was censored.', 'groupId': 'OG000', 'lowerLimit': '283', 'upperLimit': 'NA'}, {'value': '357', 'groupId': 'OG001', 'lowerLimit': '264', 'upperLimit': '1302'}]}]}], 'analyses': [{'pValue': '0.530', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm', 'description': 'Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Patient Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).'}, {'id': 'OG001', 'title': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).'}], 'classes': [{'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '401'}, {'value': '227', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '365'}]}]}], 'analyses': [{'pValue': '0.997', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm', 'description': 'Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).'}, {'id': 'OG001', 'title': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of stent placement to participant death or lost to follow-up (up to 1302 days)', 'description': 'Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).'}, {'id': 'OG001', 'title': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).'}], 'classes': [{'title': 'Tumor ingrowth', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Tumor overgrowth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Stent migration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Sludge', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Food debris in the stent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stent failed to expand', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm', 'description': 'Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).'}, {'id': 'FG001', 'title': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Alive at final follow-up', 'groupId': 'FG000', 'numSubjects': '4'}, {'comment': 'Alive at final follow-up', 'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'SEMS Obstruction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Died Unobstructed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).'}, {'id': 'BG001', 'title': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '13', 'groupId': 'BG000'}, {'value': '66', 'spread': '14', 'groupId': 'BG001'}, {'value': '66', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2010-01-08', 'resultsFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-28', 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Recurrent Biliary Obstruction', 'timeFrame': 'Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm', 'description': 'Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.'}], 'secondaryOutcomes': [{'measure': 'Patient Survival', 'timeFrame': 'Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm', 'description': 'Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From time of stent placement to participant death or lost to follow-up (up to 1302 days)', 'description': 'Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.'}, {'measure': 'Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism', 'timeFrame': 'Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm', 'description': 'Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Inoperable Tumors of the Bile Duct']}, 'referencesModule': {'references': [{'pmid': '21034891', 'type': 'RESULT', 'citation': 'Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC, Saltzman JR, Thompson CC, Forcione DG, Gostout CJ, Brugge WR. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010 Nov;72(5):907-14. doi: 10.1016/j.gie.2010.08.021.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.', 'detailedDescription': "This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).\n\nMalignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age.\n* Malignant bile duct stricture.\n* Increased bilirubin.\n* Duct stricture is ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).\n* Not an operative candidate.\n\nExclusion Criteria:\n\n* Unable to obtain consent.\n* Unable to tolerate procedure.\n* Suspected benign bile duct stricture.\n* Candidate for potentially curative surgical intervention.\n* Previous metallic biliary stent.\n* Previous bile duct surgery.'}, 'identificationModule': {'nctId': 'NCT01047332', 'acronym': 'Wallstent', 'briefTitle': 'A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures', 'orgStudyIdInfo': {'id': 'BS-816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Uncovered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).', 'interventionNames': ['Device: Uncovered Wallstent']}, {'type': 'EXPERIMENTAL', 'label': 'Partially Covered Wallstent', 'description': 'Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).', 'interventionNames': ['Device: Partially Covered Wallstent']}], 'interventions': [{'name': 'Partially Covered Wallstent', 'type': 'DEVICE', 'description': 'Partially covered wallstent', 'armGroupLabels': ['Partially Covered Wallstent']}, {'name': 'Uncovered Wallstent', 'type': 'DEVICE', 'description': 'Uncovered wallstent', 'armGroupLabels': ['Uncovered Wallstent']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David L Carr-Locke, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. David Carr-Locke, MD, FRCP', 'investigatorFullName': 'David L. Carr-Locke, MD, FRCP', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}