Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-04-17 @ 6:10 PM
Study NCT ID:
NCT02797067
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2016-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rectal Indomethacin to Prevent Post ESWL-pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '919835863@qq.com', 'phone': '13818040017', 'title': 'Yangyang Qian', 'organization': 'Changhai Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From administration of rectal indomethacin/glycerin suppositories to charge from hospital, up to one month', 'eventGroups': [{'id': 'EG000', 'title': 'Indomethacin', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.\n\nindomethacin suppository: 100mg rectal indomethacin 30min before ESWL', 'otherNumAtRisk': 685, 'deathsNumAtRisk': 685, 'otherNumAffected': 0, 'seriousNumAtRisk': 685, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Glycerin', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.\n\nGlycerin Suppository: 30min before ESWL', 'otherNumAtRisk': 685, 'deathsNumAtRisk': 685, 'otherNumAffected': 0, 'seriousNumAtRisk': 685, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Incidence of Post-ESWL Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.\n\nindomethacin suppository: 100mg rectal indomethacin 30min before ESWL'}, {'id': 'OG001', 'title': 'Glycerin', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.\n\nGlycerin Suppository: 30min before ESWL'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 months', 'description': 'Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.\n\nindomethacin suppository: 100mg rectal indomethacin 30min before ESWL'}, {'id': 'OG001', 'title': 'Glycerin', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.\n\nGlycerin Suppository: 30min before ESWL'}], 'classes': [{'title': 'Infection', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Steinstrasse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Perforation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Asymptomatic Hyperamylasemia', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': 'Hematuria', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Hematemesis', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Melena', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 months', 'description': 'Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.\n\nOther post-ESWL complications including bleeding, infection, steinstrasse and perforation.\n\nBleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments.\n\nInfection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications.\n\nPerforation is related to treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.\n\nindomethacin suppository: 100mg rectal indomethacin 30min before ESWL'}, {'id': 'OG001', 'title': 'Glycerin', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.\n\nGlycerin Suppository: 30min before ESWL'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 months', 'description': 'Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Relative Risks in the Subgroup of Potential Risk Factors for Post -ESWL Pancreatitis Will be Assessed by SPSS（Statistical Product and Service Solutions，a Statistical Software）.', 'timeFrame': 'up to 1 months', 'description': 'Potential risk factors including sex, steatorrhea, pancreas divisum, frequent attack of acute pancreatitis (≥ 1/year), diabetes, CBD（common bile duct） stenosis, alcohol consumption, multiple stones, position (the 30°-right supine position) and shock wave frequency ≥100/min.These will be assess to determine whether the treatment effect differ in these pre-specified factors.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indomethacin', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.\n\nindomethacin suppository: 100mg rectal indomethacin 30min before ESWL'}, {'id': 'FG001', 'title': 'Glycerin', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.\n\nGlycerin Suppository: 30min before ESWL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '685'}, {'groupId': 'FG001', 'numSubjects': '685'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '685'}, {'groupId': 'FG001', 'numSubjects': '685'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'BG000'}, {'value': '685', 'groupId': 'BG001'}, {'value': '1370', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Indomethacin', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.\n\nindomethacin suppository: 100mg rectal indomethacin 30min before ESWL'}, {'id': 'BG001', 'title': 'Glycerin', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.\n\nGlycerin Suppository: 30min before ESWL'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.85', 'spread': '12.32', 'groupId': 'BG000'}, {'value': '45.84', 'spread': '12.43', 'groupId': 'BG001'}, {'value': '45.35', 'spread': '12.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '491', 'groupId': 'BG000'}, {'value': '488', 'groupId': 'BG001'}, {'value': '979', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '685', 'groupId': 'BG000'}, {'value': '685', 'groupId': 'BG001'}, {'value': '1370', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-20', 'size': 541543, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-08T11:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2016-05-29', 'resultsFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-07', 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Relative Risks in the Subgroup of Potential Risk Factors for Post -ESWL Pancreatitis Will be Assessed by SPSS（Statistical Product and Service Solutions，a Statistical Software）.', 'timeFrame': 'up to 1 months', 'description': 'Potential risk factors including sex, steatorrhea, pancreas divisum, frequent attack of acute pancreatitis (≥ 1/year), diabetes, CBD（common bile duct） stenosis, alcohol consumption, multiple stones, position (the 30°-right supine position) and shock wave frequency ≥100/min.These will be assess to determine whether the treatment effect differ in these pre-specified factors.'}], 'primaryOutcomes': [{'measure': 'the Incidence of Post-ESWL Pancreatitis', 'timeFrame': 'up to 1 months', 'description': 'Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.'}], 'secondaryOutcomes': [{'measure': 'the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications', 'timeFrame': 'up to 1 months', 'description': 'Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.\n\nOther post-ESWL complications including bleeding, infection, steinstrasse and perforation.\n\nBleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments.\n\nInfection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications.\n\nPerforation is related to treatment.'}, {'measure': 'the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）', 'timeFrame': 'up to 1 months', 'description': 'Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Shock Wave lithotripsy(ESWL)', 'Prophylaxis', 'Indomethacin', 'Chronic pancreatitis'], 'conditions': ['Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '35085482', 'type': 'DERIVED', 'citation': 'Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.'}, {'pmid': '29096689', 'type': 'DERIVED', 'citation': 'Qian YY, Chen H, Tang XY, Jiang X, Qian W, Zou WB, Xin L, Li B, Qi YF, Hu LH, Zou DW, Jin ZD, Wang D, Du YQ, Wang LW, Liu F, Li ZS, Liao Z. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials. 2017 Nov 2;18(1):513. doi: 10.1186/s13063-017-2250-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.', 'detailedDescription': 'It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (\\> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient with chronic pancreatitis and pancreatic stones (\\> 5 mm in diameter) undergoing P-ESWL\n* at least 18 years old\n* provides informed consent\n\nExclusion Criteria:\n\n* readmitted to the hospital during the enrollment of the study\n* contraindications to ESWL\n* suspected or established malignancy\n* pancreatic ascites\n* receiving NSAIDs within 7 days\n* contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine \\>120 μmol/L)\n* presence of coagulopathy or received anticoagulation therapy within 3 days\n* acute pancreatitis within 3 days\n* known active cardiovascular or cerebrovascular disease\n* pregnant or breastfeeding women\n* without a rectum (ie, status post-total proctocolectomy)'}, 'identificationModule': {'nctId': 'NCT02797067', 'acronym': 'RIPEP', 'briefTitle': 'Rectal Indomethacin to Prevent Post ESWL-pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)', 'orgStudyIdInfo': {'id': 'ESWL-pancreatitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indomethacin', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.', 'interventionNames': ['Drug: indomethacin suppository']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Glycerin', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.', 'interventionNames': ['Drug: Glycerin Suppository']}], 'interventions': [{'name': 'indomethacin suppository', 'type': 'DRUG', 'description': '100mg rectal indomethacin 30min before ESWL', 'armGroupLabels': ['Indomethacin']}, {'name': 'Glycerin Suppository', 'type': 'DRUG', 'description': '30min before ESWL', 'armGroupLabels': ['Glycerin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhuan Liao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhuan Liao', 'investigatorAffiliation': 'Changhai Hospital'}}}}