Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01543256
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2012-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Evelyne.Ho@bsci.com', 'phone': '+1 508-683-4140', 'title': 'Evelyne Ho', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 3, 'seriousNumAtRisk': 80, 'deathsNumAffected': 5, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 8, 'seriousNumAtRisk': 84, 'deathsNumAffected': 3, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstruction Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholangitis/fever/jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'notes': 'among patients with a gallbladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-ERCP pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute-on-chronic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation of duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-sphincterotomy bleed', 'notes': 'among patients who had a sphincterotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Stricture Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'OG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.008', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Exact non-inferiority', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-Inferiority margin was 20%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 12-month stenting period through 24 month follow-up (approximately 12 months)', 'description': 'Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 80 participants in metal stent arm, only 62 were eligible for primary endpoint evaluation. Of 84 participants in plastic stent arm, only 70 were eligible for primary endpoint evaluation.'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events Related to the Device or Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'OG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.568', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of ERCP Procedures Through 24 Months After Initial Stent Placement.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'OG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.', 'unitOfMeasure': 'procedures', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 80 participants in metal stent arm, 1 participant failed technical success at baseline and did have a completed ERCP procedure. Of 84 participants in plastic stent arm, 2 participants failed technical success at baseline and did have a completed ERCP procedure.'}, {'type': 'SECONDARY', 'title': 'Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'OG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial stent placement procedure', 'description': 'Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stent Placement and Removal Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'OG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '182'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '144'}]}]}], 'analyses': [{'pValue': '.519', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'Length of stent placement procedures and stent removal procedures.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Number of Stents Placed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'OG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'Number of stents placed throughout study to 24 month follow-up', 'unitOfMeasure': 'number of stents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 80 participants in metal stent arm, 1 participant never had a stent placed. Of 84 participants in plastic stent arm, 2 participants never had a stent placed, 1 participant withdrew from the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'FG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'preAssignmentDetails': 'Of 172 enrolled participants, 164 met inclusion criteria and were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metal Stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nWallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.'}, {'id': 'BG001', 'title': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.\n\nCommercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '74'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '74'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Hong Kong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'India', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time since chronic pancreatitis (CP) diagnosed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'BG000', 'lowerLimit': '.1', 'upperLimit': '35.8'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '.1', 'upperLimit': '32.4'}, {'value': '1.9', 'groupId': 'BG002', 'lowerLimit': '.1', 'upperLimit': '35.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gallbladder in situ', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CP etiology alcoholic', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.'}, {'title': 'Calcifying CP', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.'}, {'title': 'Candidate for surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.'}, {'title': 'Prior plastic stent', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Biliary Sphincterotomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.'}, {'title': 'Prior pancreatic sphincterotomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.'}, {'title': 'Baseline Bilirubin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '.1', 'upperLimit': '25.3'}, {'value': '1.4', 'groupId': 'BG001', 'lowerLimit': '.2', 'upperLimit': '17.7'}, {'value': '1.3', 'groupId': 'BG002', 'lowerLimit': '.1', 'upperLimit': '25.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline Alkaline Phosphatase', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '337', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '1871'}, {'value': '262.5', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '1909'}, {'value': '299', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '1909'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-02-15', 'size': 605409, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-05T11:42', 'hasProtocol': True}, {'date': '2013-03-20', 'size': 368545, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-05T11:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2012-02-14', 'resultsFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2012-02-27', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-11', 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Stricture Resolution', 'timeFrame': 'After 12-month stenting period through 24 month follow-up (approximately 12 months)', 'description': 'Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.'}], 'secondaryOutcomes': [{'measure': 'Serious Adverse Events Related to the Device or Procedure', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.'}, {'measure': 'Number of ERCP Procedures Through 24 Months After Initial Stent Placement.', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.'}, {'measure': 'Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)', 'timeFrame': 'Initial stent placement procedure', 'description': 'Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.'}, {'measure': 'Length of Stent Placement and Removal Procedures', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'Length of stent placement procedures and stent removal procedures.'}, {'measure': 'Number of Stents Placed', 'timeFrame': 'Initial stent placement procedure to 24 month follow-up', 'description': 'Number of stents placed throughout study to 24 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['benign biliary strictures secondary to chronic pancreatitis'], 'conditions': ['Biliary Stricture']}, 'referencesModule': {'references': [{'pmid': '33741314', 'type': 'DERIVED', 'citation': 'Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months.\n\nStatistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Willing and able to comply with the study procedures and provide written informed consent to participate in the study\n* Chronic pancreatitis\n* Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12\n* Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts\n\nExclusion Criteria:\n\n* Biliary stricture of benign etiology other than chronic pancreatitis\n* Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or less for 6 months or fewer\n* Developing obstructive biliary symptoms associated with an attack of acute pancreatitis\n* Biliary stricture of malignant etiology\n* Stricture within 2 cm of common bile duct bifurcation\n* Known bile duct fistula or leak\n* Subjects for whom endoscopic techniques are contraindicated\n* Known sensitivity to any components of the stent or delivery system\n* Symptomatic duodenal stenosis (with gastric stasis)\n* Participation in another investigational study within 90 days prior to consent\n* Investigator Discretion'}, 'identificationModule': {'nctId': 'NCT01543256', 'briefTitle': 'WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis', 'orgStudyIdInfo': {'id': 'CDM00047682'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metal stents', 'description': 'The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.', 'interventionNames': ['Device: WallFlex™ Biliary RX Fully Covered Stent System RMV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plastic Stents', 'description': 'Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.', 'interventionNames': ['Device: Commercially available Plastic Stent Per Investigator preference']}], 'interventions': [{'name': 'WallFlex™ Biliary RX Fully Covered Stent System RMV', 'type': 'DEVICE', 'description': 'Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell. ("RMV" in intervention name indicates "removable")', 'armGroupLabels': ['Metal stents']}, {'name': 'Commercially available Plastic Stent Per Investigator preference', 'type': 'DEVICE', 'description': 'Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.', 'armGroupLabels': ['Plastic Stents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2042', 'city': 'Newtown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Medical Center', 'geoPoint': {'lat': -33.89835, 'lon': 151.17754}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus AKH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'H2X 3J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Hopital Saint-Luc', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': 'D-40217', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Dusseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Shatin', 'state': 'New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'zip': '500 082', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Asian Institute of Gastroenterology', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '37134', 'city': 'Verona', 'state': 'VR', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '3015', 'city': 'Rotterdam', 'state': 'CE', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': 'S-14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Universitets Sjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'D.Nageshwar Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asian Institute of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}