Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01590394
Status:
TERMINATED
Last Update Posted:
2017-10-17
First Post:
2012-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
Sponsor:
Organization:
Raw JSON
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Gostout', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to difficulty in enrolling subjects and transporting the scope for sterilization.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Pancreatic Cancer Patients', 'description': 'A large plastic biliary stent was placed in the bile duct for bile duct obstruction.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pancreatic Cancer Patients', 'description': 'A large plastic biliary stent was placed in the bile duct for bile duct obstruction.'}], 'timeFrame': '6 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not analyzed, because there were too few subjects to make the outcome measure meaningful. Principal investigator retired before any analysis could be performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pancreatic Cancer Patients', 'description': 'A large plastic biliary stent was placed in the bile duct for bile duct obstruction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled at Mayo Clinic in Rochester, Minnesota.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pancreatic Cancer Patients', 'description': 'A large plastic biliary stent was placed in the bile duct for bile duct obstruction.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Difficulty in enrolling subjects and transporting scope for sterilization', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2012-04-30', 'resultsFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-18', 'studyFirstPostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstruction', 'bile duct', 'malignant'], 'conditions': ['Stricture', 'Obstruction', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Plastic biliary stents which are a new larger size will remain free of obstructions for a longer period of time than currently used 10 French stents in cancer in the common bile duct.', 'detailedDescription': 'Malignant obstruction of the extra-hepatic bile duct often leads to jaundice and pruritus and occasionally results in cholangitis and bacteremia. Pancreatic cancer accounts for a large proportion of patients presenting with malignant extra-hepatic biliary obstruction. Most pancreatic cancers are unresectable at presentation, and palliation, including biliary decompression, is often a goal of therapy. Over the last decade, biliary decompression with endoscopically-placed stents during endoscopic retrograde cholangiopancreatography (ERCP) has largely replaced surgical bilioenteric diversion. Biliary decompression via endoscopic stenting alleviates cholestatic symptoms and improves quality of life. When compared to surgery, endoscopically placed plastic stents result in decreased morbidity and a trend towards decreased 30 day mortality. However, surgery is associated with a lower risk of recurrent biliary obstruction.\n\nStent diameter is an important factor in determining duration of biliary luminal patency. All plastic biliary stents will ultimately occlude due to deposition of bacterial biofilm. The original plastic biliary stents were 7 French (Fr) in diameter, with a patency rate of about 4 weeks. With increases in the size of the working channel of duodenoscopes, the limiting factor in what diameter stent can be deployed, 10 Fr stents were developed, with patency rates of approximately 15 weeks (3-4 months). Until recently, the largest stent that could be deployed with the current endoscopic technology using a conventional duodenoscope of acceptable outer diameter was 11.5 Fr; the limited available data suggest that these stents do not offer more prolonged luminal patency interval compared to 10 Fr stents.\n\nIn the early 1990s, self-expandable metal stents (SEMS) became available for use in palliation of malignant biliary obstruction. Once deployed, SEMS achieve larger diameters than plastic stents, which results in a longer median patency interval of approximately six to eight months.\\[3, 6, 9-12\\] Although effective, metal stents are eight to ten times more costly than plastic stents.\n\nRecently, a large working channel duodenoscope with an acceptable outer diameter has been developed. This prototype duodenoscope allows passage of larger stents, which the investigators have successfully placed in select cases using this prototype. This duodenoscope, manufactured by Olympus Medical Systems Corp., is FDA approved.\n\nThe investigators hypothesize that, with the substantially increased luminal diameter, larger plastic stents will provide more prolonged relief of obstructive jaundice in patients with malignant distal common bile duct strictures. If this proves to be true, larger plastic stents may constitute a cost-effective alternative to SEMS, especially in health care systems that cannot afford SEMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria:\n\n1. ≥ 18 and ≤ 85 years of age\n2. Malignant biliary obstruction, known or suspected\n3. Increased bilirubin or jaundice or history thereof\n4. Duct stricture (obstruction) ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts)\n5. Not an operative candidate\n\nExclusion Criteria:\n\n1. Unable to obtain consent\n2. Unable to tolerate endoscopic procedure\n3. Suspected non-malignant bile duct stricture\n4. Candidate for potentially curative surgical intervention\n5. Previous SEMS\n6. Previous bile duct surgery\n7. Diffuse liver metastasis\n8. Peritoneal metastasis by CT\n9. Presence of ascites\n10. Duodenal obstruction preventing passage of the duodenoscope to the level of the papilla\n11. Failure to cannulate bile duct during ERCP\n12. Karnofsky performance score \\< 40'}, 'identificationModule': {'nctId': 'NCT01590394', 'briefTitle': 'Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Prospective Evaluation of Luminal Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.', 'orgStudyIdInfo': {'id': '11-003154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pancreatic Cancer Patients', 'description': 'A large plastic biliary stent was placed in the bile duct.', 'interventionNames': ['Device: Large plastic biliary stent']}], 'interventions': [{'name': 'Large plastic biliary stent', 'type': 'DEVICE', 'description': 'Stent placement for bile duct obstruction.', 'armGroupLabels': ['Pancreatic Cancer Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Christopher J Gostout, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Olympus America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Christopher J. Gostout', 'investigatorAffiliation': 'Mayo Clinic'}}}}