Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-02 @ 1:24 PM
Study NCT ID:
NCT03595150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2018-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diclofenac for Prevention of Post-ERC Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label randomised controlled trial of Diclofenac as prophylaxis versus no prophylaxis for prevention of post-ERCP pancreatitis'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-ERCP pancreatitis', 'timeFrame': 'Within 30 days post-ERCP', 'description': 'Acute pancreatitis recorded in GallRiks by responsible endoscopist or surgeon. According to GallRiks criteria pancreatitis includes elevated amylase and abdominal pain of an intensity that hospital stay is warranted.'}], 'secondaryOutcomes': [{'measure': 'Adverse drug reactions', 'timeFrame': 'Within 30 days post-ERCP', 'description': 'Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding'}, {'measure': 'Mortality', 'timeFrame': 'Within 30 days post-ERCP', 'description': 'Death within 30 days after ERCP'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic Retrograde Cholangiopancreatography', 'Pancreatitis', 'Diclofenac'], 'conditions': ['Common Bile Duct Diseases']}, 'descriptionModule': {'briefSummary': 'The study aims at assessing the effectiveness of Diclofenac for prevention of post-ERCP pancreatitis. It will be undertaken embedded in the Swedish national register for Gallstone surgery and ERCP (GallRiks). Patients are randomised to Diclofenac prior to the ERCP or no prophylaxis. GallRiks is used to identify which patients fulfill the eligibility criteria and which patients develop pancreatitis after the ERCP.', 'detailedDescription': 'Endoscopic Retrograde Cholangiopancreatography (ERCP) is a procedure commonly performed for diagnosing changes in the bile ducts or managing outflow obstruction. Although ERCP may in most cases be performed safely, there is a risk of developing acute pancreatitis following the procedure. The risk has been estimated to 5-10%, with an increased risk in women, younger patients and in case the cannulation is difficult.\n\nPhospholipase 2 is crucial in the pathogenesis of acute pancreatitis. As Diclofenac is a potent inhibitor of Phospholipase 2, it has been suggested that it may be used for prevention of post-ERCP pancreatitis. There is some evidence for the effectiveness of Diclofenac, but more studies are needed to confirm that it reduces the risk of post-ERCP pancreatitis.\n\nIn order to test whether Diclofenac reduces the risk for post-ERCP pancreatitis, a register-based randomized controlled study is planned. The study will be conducted embedded in the Swedish Register for Gallstone Surgery and ERCP (GallRiks). GallRiks includes data corresponding to the eligibility criteria as well as outcome measures. GallRiks will also be used to record which patients have been screened for inclusion.\n\nPatients who meet the eligibility criteria are invited to the study. If they accept inclusion, they are randomized to 100 mg Diclofenac prior to the ERCP or np prophylaxis. No blinding is done.\n\nThe aim is to include 1000 patients. When 500 patients have been included, an interim analysis will be performed, comparing the incidence of pancreatitis and mortality in the two groups. A retrospective review of the patient records will be performed for those who develop pancreatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing ERCP\n\nExclusion Criteria:\n\n* Decision to perform ERCP taken intraoperatively\n* Intolerance/allergy against NSAID\n* Patients taking NSAID daily\n* Severe cardiac fail (ASA\\>4)\n* Kidney failure (GFR\\<30 ml/min)\n* Coagulation disorder\n* History of peptic ulcer bleeding\n* History of abdominoperineal resection\n* Pregnancy\n* Patients who do not understand Swedish'}, 'identificationModule': {'nctId': 'NCT03595150', 'briefTitle': 'Diclofenac for Prevention of Post-ERC Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Diclofenac for Prevention of Post-ERC Pancreatitis', 'orgStudyIdInfo': {'id': 'Post-ERCP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diclofenac', 'description': '100 mg Diclofenac rectally prior to the ERCP', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'NO_INTERVENTION', 'label': 'No prophylaxis', 'description': 'No prophylaxis'}], 'interventions': [{'name': 'Diclofenac', 'type': 'DRUG', 'description': 'Diclofenac rectally given before the ERCP to prevent pancreatitis', 'armGroupLabels': ['Diclofenac']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gabriel Sandblom, Ass Prof', 'role': 'CONTACT', 'email': 'gabriel.sandblom@ki.se', 'phone': '+46704158218'}], 'overallOfficials': [{'name': 'Gabriel Sandblom, Ass Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Senior Consultant', 'investigatorFullName': 'Gabriel Sandblom', 'investigatorAffiliation': 'Karolinska Institutet'}}}}