Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-17 @ 1:23 AM
Study NCT ID:
NCT01774604
Status:
TERMINATED
Last Update Posted:
2016-11-04
First Post:
2013-01-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007213', 'term': 'Indomethacin'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jlevenick@hmc.psu.edu', 'phone': '603-667-1332', 'title': 'John M. Levenick', 'organization': 'Penn State Hershey Medical Center/Dartmouth-Hitchcock Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "The study was terminated due to indomethacin's lack of efficacy after 449 patients had been enrolled. Thus the study may be underpowered to draw conclusions about the role of indomethacin in preventing post ERCP pancreatitis"}}, 'adverseEventsModule': {'timeFrame': 'From randomization to 30 days after ERCP', 'eventGroups': [{'id': 'EG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1', 'otherNumAtRisk': 223, 'otherNumAffected': 4, 'seriousNumAtRisk': 223, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo', 'otherNumAtRisk': 226, 'otherNumAffected': 6, 'seriousNumAtRisk': 226, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Gastrointestinal Bleeding', 'notes': 'Patients with any type of gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Severe Acute Pancreatitis Leading to Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration Post-Procedure Leading to Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Who Developed Acute Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients who developed pancreatitis following ERCP based on Atlanta Classification', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient who randomized into the study and received either rectal indomethacin or placebo'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Developed Severe Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients with severe acute pancreatitis based on the Atlanta Classification', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Assess the number of patients who developed severe acute pancreatitis'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Developed Moderately Severe Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients with moderately severe pancreatitis based on Atlanta Classification', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Developed Mild Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patient who developed mild acute pancreatitis based on the Atlanta Classification', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Developed Gastrointestinal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patient Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients who died from any cause from the time of ERCP until 30 days post-procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With 30 Days Hospital Re-admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until 30 days after ERCP', 'description': 'Number of patients admitted to the hospital for any cause following ERCP', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '226'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All patients who presented to Dartmouth-Hitchcock Medical Center for Endoscopic Retrograde Cholangiopancreatography (ERCP) for any reason between March 2013 and December 2014'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Indomethacin', 'description': 'Indomethacin 100 mg PR x 1 in peri-procedural period\n\nIndomethacin: 100 mg Indomethacin PR x 1'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo suppositories (#2)\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '23.7', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '19.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Indication', 'classes': [{'title': 'Acute Cholangitis', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Choledocholithiasis', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'Malignant Biliary Obstruction', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Biliary Stent Change', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Biliary Leak', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Increased Liver Tests/Jaundice', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Pancreatic Stricture', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Suspected Sphincter of Oddi Dysfunction (SOD)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Pancreatic Leak/Disruption', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Pancreatic Duct Stone', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Recurrent Acute Pancreatitis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Ampullectomy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of post-ERCP Pancreatitis', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Previous Sphincterotomy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous ERCP', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Difficult Cannulation', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Difficult Cannulation was defined by \\>8 attempts at cannulation', 'unitOfMeasure': 'participants'}, {'title': 'Precut Biliary Sphincterotomy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Therapeutic Biliary Sphincterotomy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Therapeutic Pancreatic Sphincterotomy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Minor Duct Sphincterotomy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Balloon Dilation of Biliary Sphincter', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Wire Cannulation of Pancreatic Duct', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pancreatography', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pancreatic Acinarization', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Biliary Strent Placement', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pancreatic Stent Placement', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Trainee Involvement', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Concomitant Endoscopic Ultrasound with Fine Needle Aspiration (EUS/FNA)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Periprocedural Fluid Volume', 'classes': [{'categories': [{'measurements': [{'value': '705', 'spread': '335', 'groupId': 'BG000'}, {'value': '703', 'spread': '355', 'groupId': 'BG001'}, {'value': '704', 'spread': '345', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milliliters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All patient randomized to receive rectal indomethacin or placebo'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}}, 'statusModule': {'whyStopped': 'Futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-28', 'studyFirstSubmitDate': '2013-01-21', 'resultsFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-29', 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Who Developed Acute Pancreatitis', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients who developed pancreatitis following ERCP based on Atlanta Classification'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Developed Severe Pancreatitis', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients with severe acute pancreatitis based on the Atlanta Classification'}, {'measure': 'Number of Patients Who Developed Moderately Severe Pancreatitis', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients with moderately severe pancreatitis based on Atlanta Classification'}, {'measure': 'Number of Patients Who Developed Mild Pancreatitis', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patient who developed mild acute pancreatitis based on the Atlanta Classification'}, {'measure': 'Number of Patients Who Developed Gastrointestinal Bleeding', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure'}, {'measure': 'Number of Patient Deaths', 'timeFrame': 'From randomization to 30 days after ERCP', 'description': 'Number of patients who died from any cause from the time of ERCP until 30 days post-procedure'}, {'measure': 'Number of Patients With 30 Days Hospital Re-admission', 'timeFrame': 'From randomization until 30 days after ERCP', 'description': 'Number of patients admitted to the hospital for any cause following ERCP'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post ERCP acute pancreatitis', 'Post Fine Needle Aspiration (FNA) acute pancreatitis', 'Indomethacin', 'Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)'], 'conditions': ['Post-ERCP Acute Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '26775631', 'type': 'BACKGROUND', 'citation': 'Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Scheduled for an ERCP at Dartmouth-Hitchcock\n2. Age greater than 18 years old\n3. Ability to provide written informed consent\n\nExclusion Criteria:\n\n1. Inability to provide written informed consent\n2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis\n3. Current ongoing acute pancreatitis\n4. Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)\n5. Contra-indication to NSAID therapy (creatinine level \\>1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)\n6. Pregnant or nursing mothers'}, 'identificationModule': {'nctId': 'NCT01774604', 'briefTitle': 'Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Rectal Indomethacin to Prevent Post-ERCP Pancreatitis', 'orgStudyIdInfo': {'id': 'CPHS#23749'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indomethacin', 'description': 'Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period', 'interventionNames': ['Drug: Indomethacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo suppositories (#2)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Indomethacin', 'type': 'DRUG', 'description': '100 mg Indomethacin PR x 1', 'armGroupLabels': ['Indomethacin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'John M Levenick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}