Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-02-26 @ 11:04 AM
Study NCT ID:
NCT02002650
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2013-12-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rectal Indomethacin to Prevent Post-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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fmmulh@163.com', 'phone': '862984771536', 'title': 'Hui Luo', 'organization': 'Xijing hospital of digestive diseases'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Firstly, patients could not be blinded to the treatment assignment. Secondly, it remains unclear if patients with prior EST will benefit from rectal indomethacin. Thirdly, the findings need to be validated in different clinical settings.'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-ERCP Group', 'description': 'Pre-ERCP rectal Indomethacin in all patients.\n\nPre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.', 'otherNumAtRisk': 1297, 'otherNumAffected': 26, 'seriousNumAtRisk': 1297, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Post-ERCP Group', 'description': 'Post-ERCP rectal Indomethacin in high-risk patients.\n\nPost-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.', 'otherNumAtRisk': 1303, 'otherNumAffected': 33, 'seriousNumAtRisk': 1303, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Mild bleeding', 'notes': 'Clinical evidence of bleeding (ie, not just endoscopic); Hb level drop \\<3 g; no need for transfusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1297, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1303, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Mild bleeding'}, {'term': 'Mild biliary infection', 'notes': 'Mild biliary infection was defined as a temperature of more than 38°C for 24-48 h after the procedure, thought to have a biliary cause (colicky pain and cholestasis/jaundice) without evidence of other concomitant infections.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1297, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1303, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Miliary infection'}, {'term': 'Mild perforation', 'notes': 'Possible, or only very slight leak of fluid or contrast dye; treatable by fluids and suction for ≤3d', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Mild perforation'}, {'term': 'Pulmonary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1303, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Pulmonary infection'}, {'term': 'Incomplete bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1297, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Incomplete bowel obs'}], 'seriousEvents': [{'term': 'Moderate to severe bleeding', 'notes': 'Moderate to severe bleeding was defined as clinically significant bleeding with hemoglobin level drop ≥3g with the need for transfusion, angiographic intervention or surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1297, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1303, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Bleeding'}, {'term': 'Moderate to severe biliary infection', 'notes': 'Febrile or septic illness requiring \\>3 d of hospital treatment or need endoscopic or percutaneous intervention.\n\nSeptic shock or surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1297, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1303, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Biliary infection'}], 'frequencyThreshold': '0.01'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-ERCP Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '1303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-ERCP Group', 'description': 'Pre-ERCP rectal Indomethacin in all patients.\n\nPre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.'}, {'id': 'OG001', 'title': 'Post-ERCP Group', 'description': 'Post-ERCP rectal Indomethacin in high-risk patients.\n\nPost-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Moderate-to-severe Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '1303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-ERCP Group', 'description': 'Pre-ERCP rectal Indomethacin in all patients.\n\nPre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.'}, {'id': 'OG001', 'title': 'Post-ERCP Group', 'description': 'Post-ERCP rectal Indomethacin for high-risk patients.\n\nPost-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-ERCP Group', 'description': 'Pre-ERCP rectal Indomethacin in all patients.\n\nPre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.'}, {'id': 'FG001', 'title': 'Post-ERCP Group', 'description': 'Post-ERCP rectal Indomethacin in high-risk patients.\n\nPost-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1297'}, {'groupId': 'FG001', 'numSubjects': '1303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1297'}, {'groupId': 'FG001', 'numSubjects': '1303'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From Dec 15, 2013 to Sep 21, 2015, 5325 consecutive patients undergoing ERCP in six centers in China were considered for the study.', 'preAssignmentDetails': 'After screening, 2725 patients were excluded: 193 did not meet inclusion criteria, 2304 met exclusion criteria and 228 patients declined to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'BG000'}, {'value': '1303', 'groupId': 'BG001'}, {'value': '2600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-ERCP Group', 'description': 'Pre-ERCP rectal Indomethacin in all patients.\n\nPre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.'}, {'id': 'BG001', 'title': 'Post-ERCP Group', 'description': 'Post-ERCP rectal Indomethacin in high-risk patients.\n\nPost-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '72'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '74'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '688', 'groupId': 'BG000'}, {'value': '693', 'groupId': 'BG001'}, {'value': '1381', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '609', 'groupId': 'BG000'}, {'value': '610', 'groupId': 'BG001'}, {'value': '1219', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'High-risk patients', 'classes': [{'categories': [{'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '586', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'met at least one of the major criteria - clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, ≥8 cannulation attempts, pneumatic dilatation of an intact biliary sphincter, or ampullectomy.\n\nor met two or more of the minor criteria - age\\<50 and female gender, a history of recurrent pancreatitis (≥2 episodes), ≥3 injections of contrast into the pancreatic duct with ≥1 injection to the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-27', 'studyFirstSubmitDate': '2013-12-01', 'resultsFirstSubmitDate': '2016-04-17', 'studyFirstSubmitQcDate': '2013-12-01', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-21', 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-ERCP Pancreatitis', 'timeFrame': '30 days', 'description': 'Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.'}], 'secondaryOutcomes': [{'measure': 'Moderate-to-severe Pancreatitis', 'timeFrame': '30 days', 'description': 'Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Indomethacin, pancreatitis, ERCP'], 'conditions': ['Post-ERCP Acute Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '23164513', 'type': 'RESULT', 'citation': 'Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc. 2012 Dec;76(6):1152-9. doi: 10.1016/j.gie.2012.08.021.'}, {'pmid': '22494121', 'type': 'RESULT', 'citation': 'Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.'}, {'pmid': '27133971', 'type': 'DERIVED', 'citation': 'Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing diagnostic or therapeutic ERCP.\n\nExclusion Criteria:\n\n* Unwillingness or inability to consent for the study;\n* Age \\< 18 years old;\n* Intrauterine pregnancy;\n* Breastfeeding mother;\n* Standard contraindications to ERCP;\n* Allergy to NSAIDs;\n* Received NSAIDs in prior 7 days;\n* Renal failure (Cr \\>1.4mg/dl=120umol/l);\n* Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;\n* Acute pancreatitis within 72 hours;\n* Known pancreatic head mass;\n* Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;\n* ERCP for biliary stent removal or exchange without anticipated pancreatogram;\n* Known active cardiovascular or cerebrovascular disease.\n* Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;'}, 'identificationModule': {'nctId': 'NCT02002650', 'acronym': 'Indomethacin', 'briefTitle': 'Rectal Indomethacin to Prevent Post-ERCP Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20131106-7'}, 'secondaryIdInfos': [{'id': '20131106-7', 'type': 'OTHER', 'domain': 'Ethics committee of Xijing Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-ERCP group', 'description': 'Pre-ERCP rectal Indomethacin in all patients.', 'interventionNames': ['Drug: Pre-ERCP rectal Indomethacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Post-ERCP group', 'description': 'Post-ERCP rectal Indomethacin in high-risk patients.', 'interventionNames': ['Drug: Post-operational Rectal Indomethacin']}], 'interventions': [{'name': 'Pre-ERCP rectal Indomethacin', 'type': 'DRUG', 'description': 'Rectal Indomethacin was administrated within 30min before ERCP in all patients.', 'armGroupLabels': ['Pre-ERCP group']}, {'name': 'Post-operational Rectal Indomethacin', 'type': 'DRUG', 'description': 'Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.', 'armGroupLabels': ['Post-ERCP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of NingXia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710054', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'No. 451 Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "The First Affiliated Hospital Of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '830002', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Urumqi General Hospital of Lanzhou Military Region', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}], 'overallOfficials': [{'name': 'Yanglin Pan, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xijing Hospital of Digestive Diseases.The Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Yanglin Pan', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}