Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT01964066
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}, {'id': 'D013662', 'term': 'Tea'}, {'id': 'D015360', 'term': 'Analgesia, Epidural'}, {'id': 'D000767', 'term': 'Anesthesia, Epidural'}, {'id': 'D011292', 'term': 'Premedication'}, {'id': 'D058126', 'term': 'Balanced Anesthesia'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000768', 'term': 'Anesthesia, General'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-10-13', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevention of post-ERCP pancreatitis', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['therapeutic ERCP', 'prevention of post-ERCP pancreatitis', 'thoracic epidural analgesia'], 'conditions': ['Post-ERCP Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has been the most frequent adverse effect of endoscopic transpapillary interventions. We sought to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP pancreatitis.\n\nBetween 2008 and 2013, a randomized study of the results of endoscopic treatment of 491 patients was conducted. The first group of patients (N=247) received thoracic epidural analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a narcotic analgesic. To detect statistically significant differences between research groups adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.', 'detailedDescription': 'Preoperatively the subjects were randomly assigned (by using sealed envelopes - blind randomization) into two groups, 250 patients each.\n\nThe patients of the first group had TEA applied during the ERCP procedure; other methods of pain relief were applied to the patients of the second (control) group.\n\nThe first group (TEA group) of patients received the following premedication: atropine sulfate 0.5-1 mg, midazolan 5 mg. The puncture and catheterization of the epidural space was carried out according to standard procedure between thoracic vertebrae VII-VIII. Half an hour before performing ERCP ropivacaine 0.5% -10 ml. was injected into the epidural space.\n\nThe second group (control group) of patients received the following premedication: atropine sulfate 0.5 -1 mg, midazolan 5 mg, trimeperidine 2% -1 ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '92 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with performed therapeutic ERCP;\n* The ERCP procedure was performed in a patient for the first time;\n* Prior to the ERCP procedure the patient didn't have any clinical signs of acute pancreatitis.\n\nExclusion criteria:\n\n\\- Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others)."}, 'identificationModule': {'nctId': 'NCT01964066', 'briefTitle': 'Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Volgograd State Medical University'}, 'officialTitle': 'Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis', 'orgStudyIdInfo': {'id': '124/2007/12/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERCP & Thoracic epidural analgesia', 'description': 'Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.', 'interventionNames': ['Procedure: ERCP', 'Procedure: Thoracic epidural analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ERCP & Premedication', 'description': 'Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.', 'interventionNames': ['Procedure: ERCP', 'Procedure: Premedication']}], 'interventions': [{'name': 'ERCP', 'type': 'PROCEDURE', 'otherNames': ['endoscopic transpapillary intervention'], 'description': 'Endoscopic retrograde cholangiopancreatography balloon dilatation', 'armGroupLabels': ['ERCP & Premedication', 'ERCP & Thoracic epidural analgesia']}, {'name': 'Thoracic epidural analgesia', 'type': 'PROCEDURE', 'otherNames': ['Epidural analgesia', 'Epidural anaesthesia'], 'description': 'Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)', 'armGroupLabels': ['ERCP & Thoracic epidural analgesia']}, {'name': 'Premedication', 'type': 'PROCEDURE', 'otherNames': ['anociassociation', 'anocithesia', 'prenarcosis'], 'description': 'For premedication used trimeperidine 2%-1ml intravenously.', 'armGroupLabels': ['ERCP & Premedication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400079', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Clinic №1 of Volgograd State Medical University', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}], 'overallOfficials': [{'name': 'Mihail Turovets, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinic №1 of Volgograd state medical university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Volgograd State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}