Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01239056
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2010-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010192', 'term': 'Pancreatic Pseudocyst'}], 'ancestors': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Peter.Draganov@medicine.ufl.edu', 'phone': '(352) 273-9472', 'title': 'Dr. Peter V. Draganov', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Pancreatic Pseudocysts', 'description': 'Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'posttransmural drainage fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'post-ERCP pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'pseudocyst infection requiring surgery', 'notes': 'Major complication from transmural drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pancreatic Pseudocysts', 'description': 'Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.'}], 'classes': [{'title': 'Resolution of Pseudocyst', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Unresolved Pseudocyst', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 12 weeks after baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pancreatic Pseudocysts', 'description': 'Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.'}], 'classes': [{'title': 'technical success', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'technical failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst .\n\nTechnical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pancreatic Pseudocysts', 'description': 'Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.'}], 'classes': [{'title': 'Pseudocyst infection requiring surgery', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Posttransmural drainage fever', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PostEndoscopic retrograde cholangiopancreatography', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pancreatic Pseudocysts', 'description': 'Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There were 22 signed informed consents, however after Endoscopic ultrasound imaging, 2 participants were excluded due to characteristics of the cyst cavity. Therefore, 20 participants underwent transgastric drainage of pancreatic pseudocysts by use of the fully covered self-expanding metal stents (CSEMS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pancreatic Pseudocysts', 'description': 'Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pseudocyst diameter', 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'BG000', 'lowerLimit': '5.5', 'upperLimit': '23'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2010-11-05', 'resultsFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-24', 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen', 'timeFrame': 'baseline', 'description': 'Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst .\n\nTechnical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst.'}], 'secondaryOutcomes': [{'measure': 'Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).', 'timeFrame': '6 to 12 weeks after baseline'}, {'measure': 'Adverse Events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Pseudocysts']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have a medical indication for endoscopic drainage of pancreatic pseudocyst and are referred for the procedure as part of their standard medical care will be considered for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is 18 years or older\n2. Subject has pancreatic pseudocyst\n3. Subject has medical indication for drainage of the pancreatic pseudocyst\n4. Subject must be able to give informed consent\n\nExclusion Criteria:\n\n1. Any contraindication to endoscopic pseudocyst drainage\n2. Subject is unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01239056', 'briefTitle': 'Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent', 'orgStudyIdInfo': {'id': 'Pancreatic Pseudocyst'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pancreatic Pseudocysts', 'description': 'All adult patients who have a clinical indication to undergo an endoscopic drainage of a pancreatic pseudocyst.', 'interventionNames': ['Procedure: Endoscopy']}], 'interventions': [{'name': 'Endoscopy', 'type': 'PROCEDURE', 'description': 'Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.', 'armGroupLabels': ['Pancreatic Pseudocysts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands UF Endoscopy', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Peter V draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}