Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT04608760
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2020-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Acute Pancreatitis After Endoscopic Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2020-10-24', 'studyFirstSubmitQcDate': '2020-10-24', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week', 'timeFrame': '1 week', 'description': 'Summ points 0 - pancreatitis, 1 - mild pancreatitis, 2 - severe pancreatitis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography'], 'conditions': ['Cholangiolitis', 'Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to develop a method for the prevention of acute pancreatitis after minimally invasive interventions of the bile ducts using a drug regimen.', 'detailedDescription': 'A prospective, randomized, single-center study is planned to identify the most effective drug regimen in order to prevent the development of acute pancreatitis after transpapillary interventions of the bile ducts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with cholangiolithiasis.\n2. Patients with benign formations of the bile ducts.\n3. Patients with malignant formations of the bile ducts.\n4. Patients with extrahepatic bile duct cysts.\n5. Patients with biliary hypertension of unknown etiology.\n6. Patients with cholangitis.\n7. Patients with extrahepatic bile duct strictures.\n8. Patients suffering from oncopathology of the head of the pancreas, complicated by obstructive jaundice.\n9. Patients with malignant pathology of the pancreas.\n10. Patients with benign pancreatic pathology.\n\nExclusion Criteria:\n\n1. ASA scale\\> III (severe concomitant cardiovascular pathology)\n2. Severe pathology of the respiratory system.\n3. Acute period of myocardial infarction.\n4. Acute period of cerebral infarction.'}, 'identificationModule': {'nctId': 'NCT04608760', 'briefTitle': 'Prevention of Acute Pancreatitis After Endoscopic Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Vitebsk State Medical University'}, 'officialTitle': 'Prevention of Acute Pancreatitis After Endoscopic Interventions', 'orgStudyIdInfo': {'id': 'Interventional'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Meksibel', 'description': 'Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure', 'interventionNames': ['Drug: Meksibel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indometacin', 'description': 'Into the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure', 'interventionNames': ['Drug: Meksibel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meloksicam', 'description': 'Intravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure', 'interventionNames': ['Drug: Meksibel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oktride', 'description': 'Intravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure', 'interventionNames': ['Drug: Meksibel']}], 'interventions': [{'name': 'Meksibel', 'type': 'DRUG', 'description': '2 ml solution', 'armGroupLabels': ['Indometacin', 'Meksibel', 'Meloksicam', 'Oktride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'VSMU', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}], 'overallOfficials': [{'name': 'Yury Arlouski, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vitebsk State Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitebsk State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}