Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-22 @ 5:12 AM
Study NCT ID:
NCT01929460
Status:
COMPLETED
Last Update Posted:
2016-02-15
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'regional-research-committee@kp.org', 'phone': '800-954-8000', 'title': 'Karl Kwok, MD', 'organization': 'Kaiser Permanente, Los Angeles Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were prospectively monitored during the study period (1/1/2014-12/31/2014) at 2, 4, 6 weeks post procedure, or if the patient contacted the on-call research staff at any time after hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Drug (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention Group', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)', 'otherNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'pain', 'notes': '2 cases deemed unrelated to the procedure (1, nephrolithiasis; 1, chronic abdominal pain).\n\n1 case deemed probably unrelated\n\n1 case deemed possibly related but resolved uneventfully with conservative measures only', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'pain'}], 'seriousEvents': [{'term': 'pancreatitis', 'notes': 'one patient in the placebo arm was admitted for post-procedure pancreatitis. Recovered without incident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'pancreatitis'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 2 weeks after procedure', 'description': 'first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4 weeks after procedure', 'description': 'second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 weeks after procedure', 'description': 'third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'six weeks', 'description': 'Number of participants with adverse drug reactions', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'six weeks after procedure', 'description': 'Number of patients with procedure-related complications', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Cyst Fluid Carcinoembryonic Antigen (CEA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '214.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1982'}, {'value': '2466.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '24056'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'six weeks', 'description': 'Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Cyst Fluid Amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '3729', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '7200'}, {'value': '1944.5', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '7200'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'six weeks', 'description': 'Mean cyst fluid amylase for classification of mucinous cystic lesions', 'unitOfMeasure': 'Units/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Cyst Fluid Carcinoembryonic Antigen (CEA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '74.5'}, {'value': '24.9', 'groupId': 'OG001', 'lowerLimit': '0.35', 'upperLimit': '248.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'six weeks', 'description': 'Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Cyst Fluid Amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'OG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'classes': [{'categories': [{'measurements': [{'value': '4006.5', 'groupId': 'OG000', 'lowerLimit': '167.5', 'upperLimit': '7200'}, {'value': '239', 'groupId': 'OG001', 'lowerLimit': '144', 'upperLimit': '2930'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'six weeks', 'description': 'Median cyst fluid amylase for classification of mucinous cystic lesions', 'unitOfMeasure': 'Units/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'FG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciprofloxacin (Standard Group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.\n\nCiprofloxacin'}, {'id': 'BG001', 'title': 'Placebo (Intervention Group)', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.\n\nPlacebo (for ciprofloxacin)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '85'}, {'value': '68.5', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '82'}, {'value': '68.3', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of fine needle aspiration (FNA) passes', 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.38', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.42', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'passes', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2013-08-13', 'resultsFirstSubmitDate': '2015-10-07', 'studyFirstSubmitQcDate': '2013-08-22', 'lastUpdatePostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-25', 'studyFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration', 'timeFrame': 'At 2 weeks after procedure', 'description': 'first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)'}, {'measure': 'Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration', 'timeFrame': 'At 4 weeks after procedure', 'description': 'second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)'}, {'measure': 'Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration', 'timeFrame': 'At 6 weeks after procedure', 'description': 'third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)'}], 'secondaryOutcomes': [{'measure': 'Adverse Drug Reactions', 'timeFrame': 'six weeks', 'description': 'Number of participants with adverse drug reactions'}, {'measure': 'Procedure-related Complications', 'timeFrame': 'six weeks after procedure', 'description': 'Number of patients with procedure-related complications'}, {'measure': 'Mean Cyst Fluid Carcinoembryonic Antigen (CEA)', 'timeFrame': 'six weeks', 'description': 'Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions'}, {'measure': 'Mean Cyst Fluid Amylase', 'timeFrame': 'six weeks', 'description': 'Mean cyst fluid amylase for classification of mucinous cystic lesions'}, {'measure': 'Median Cyst Fluid Carcinoembryonic Antigen (CEA)', 'timeFrame': 'six weeks', 'description': 'Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions'}, {'measure': 'Median Cyst Fluid Amylase', 'timeFrame': 'six weeks', 'description': 'Median cyst fluid amylase for classification of mucinous cystic lesions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Cysts']}, 'referencesModule': {'references': [{'pmid': '15758904', 'type': 'BACKGROUND', 'citation': 'Jacobson BC, Baron TH, Adler DG, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; American Society for Gastrointestinal Endoscopy. ASGE guideline: The role of endoscopy in the diagnosis and the management of cystic lesions and inflammatory fluid collections of the pancreas. Gastrointest Endosc. 2005 Mar;61(3):363-70. doi: 10.1016/s0016-5107(04)02779-8. No abstract available.'}, {'pmid': '15765442', 'type': 'BACKGROUND', 'citation': 'Lee LS, Saltzman JR, Bounds BC, Poneros JM, Brugge WR, Thompson CC. EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Clin Gastroenterol Hepatol. 2005 Mar;3(3):231-6. doi: 10.1016/s1542-3565(04)00618-4.'}]}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics.', 'detailedDescription': 'With the increased use of cross sectional imaging, there appears to be an increasing prevalence of pancreatic cysts being incidentally discovered.\n\nA critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration (EUS-FNA).\n\nCurrent guidelines suggest the use of antibiotics in cyst aspiration, usually 3 days after the procedure. However, these recommendations are based on limited data from over 15 years ago. More recent retrospective observations suggest equivalent safety when little, or even no antibiotics are given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation\n\nExclusion Criteria:\n\n* Patients outside the age range\n* Patient-related factors (unable to provide consent, unable to understand English, allergic to cipro)\n* High-risk patients for infective endocarditis\n* Bacterial infection or use of antibiotics within 6 weeks of EUS\n* Pancreatitis within the past 6 months\n* Underlying immunosuppression (for example, uncontrolled diabetes - such as hemoglobin A1c above 7 or glucose \\> 180; renal failure; cirrhosis; pre-existing malignancy especially hematologic malignancy such as leukemia / lymphoma / multiple myeloma; HIV/AIDS)\n* Currently taking immunosuppressive medications (for conditions such as rheumatoid arthritis, inflammatory bowel disease, organ transplant)\n* Radiographic or endosonographic evidence of cyst cavity debris / necrotic debris\n* Severe systemic disease (for example, NYHA class III or IV heart failure, oxygen-dependent COPD)'}, 'identificationModule': {'nctId': 'NCT01929460', 'briefTitle': 'A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Drug (Standard group)', 'description': 'Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.\n\nCiprofloxacin 500mg by mouth twice a day for three days.', 'interventionNames': ['Drug: Ciprofloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intervention group', 'description': 'Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration\n\nOral Placebo, one cap twice a day for three days.', 'interventionNames': ['Other: Placebo (for ciprofloxacin)']}], 'interventions': [{'name': 'Ciprofloxacin', 'type': 'DRUG', 'otherNames': ['Cipro'], 'description': 'ciprofloxacin oral capsule (one capsule twice a day for 3 days)', 'armGroupLabels': ['Drug (Standard group)']}, {'name': 'Placebo (for ciprofloxacin)', 'type': 'OTHER', 'otherNames': ['sugar pill formulated to mimic oral ciprofloxacin'], 'description': 'oral placebo capsule (one capsule twice a day for 3 days)', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente, Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Karl Kwok, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}