Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT03708458
Status:
UNKNOWN
Last Update Posted:
2018-10-18
First Post:
2018-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2018-10-14', 'studyFirstSubmitQcDate': '2018-10-14', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who develop post ERCP pancreatitis', 'timeFrame': '24 hours post ERCP', 'description': 'Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic retrograde cholangiopancreatography (ERCP)', 'post-ERCP pancreatitis (PEP)', "Nonsteroidal anti-inflammatory drugs (NSAID's)", 'acetylcysteine (ACC)'], 'conditions': ['Post-ERCP Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '25148137', 'type': 'BACKGROUND', 'citation': 'Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.'}, {'pmid': '24099466', 'type': 'BACKGROUND', 'citation': 'Yaghoobi M, Rolland S, Waschke KA, McNabb-Baltar J, Martel M, Bijarchi R, Szego P, Barkun AN. Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013 Nov;38(9):995-1001. doi: 10.1111/apt.12488. Epub 2013 Sep 16.'}, {'pmid': '26775631', 'type': 'BACKGROUND', 'citation': 'Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9.'}, {'pmid': '26290647', 'type': 'BACKGROUND', 'citation': 'Gooshe M, Abdolghaffari AH, Nikfar S, Mahdaviani P, Abdollahi M. Antioxidant therapy in acute, chronic and post-endoscopic retrograde cholangiopancreatography pancreatitis: An updated systematic review and meta-analysis. World J Gastroenterol. 2015 Aug 14;21(30):9189-208. doi: 10.3748/wjg.v21.i30.9189.'}, {'pmid': '26074713', 'type': 'BACKGROUND', 'citation': 'Fuentes-Orozco C, Davalos-Cobian C, Garcia-Correa J, Ambriz-Gonzalez G, Macias-Amezcua MD, Garcia-Renteria J, Rendon-Felix J, Chavez-Tostado M, Cuesta-Marquez LA, Alvarez-Villasenor AS, Cortes-Flores AO, Gonzalez-Ojeda A. Antioxidant drugs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis: What does evidence suggest? World J Gastroenterol. 2015 Jun 7;21(21):6745-53. doi: 10.3748/wjg.v21.i21.6745.'}, {'pmid': '15990827', 'type': 'BACKGROUND', 'citation': 'Katsinelos P, Kountouras J, Paroutoglou G, Beltsis A, Mimidis K, Zavos C. Intravenous N-acetylcysteine does not prevent post-ERCP pancreatitis. Gastrointest Endosc. 2005 Jul;62(1):105-11. doi: 10.1016/s0016-5107(05)01574-9.'}, {'pmid': '22494121', 'type': 'BACKGROUND', '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': 'BACKGROUND', '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': 'The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 18 years and older\n* diagnosis of choledocholithiasis\n* indication for ERCP procedures\n* willingness to participate in the study\n* the ability to sign the informed consent\n\nExclusion Criteria:\n\n* presence of acute pancreatitis or other inflammatory diseases at admission\n* pregnancy\n* contraindication for NSAID administration\n* recent episode of upper digestive bleeding (less than one month)\n* hypersensibility to antioxidants hypersensibility to antioxidants\n* the necessity of a prophylactic pancreatic stent insertion\n* patients' disapproval to take part in the study"}, 'identificationModule': {'nctId': 'NCT03708458', 'briefTitle': 'Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Grigore T. Popa University of Medicine and Pharmacy'}, 'officialTitle': 'Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis', 'orgStudyIdInfo': {'id': 'PEP_2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP', 'interventionNames': ['Drug: indomethacin suppository']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP', 'interventionNames': ['Drug: indomethacin suppository', 'Drug: N-acetylcysteine (NAC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP', 'interventionNames': ['Drug: indomethacin suppository']}], 'interventions': [{'name': 'indomethacin suppository', 'type': 'DRUG', 'description': 'the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens', 'armGroupLabels': ['Control group', 'Group A', 'Group B']}, {'name': 'N-acetylcysteine (NAC)', 'type': 'DRUG', 'description': 'the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'cod 700111', 'city': 'Iași', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'GHEORGHE BALAN, PROFESSOR', 'role': 'CONTACT', 'email': 'drbalanumfiasi@yahoo.com', 'phone': '+40732402845'}], 'facility': 'Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of Iași', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}], 'centralContacts': [{'name': 'LAURA PAVEL, PhD Student', 'role': 'CONTACT', 'email': 'laura_pavel_88@yahoo.com', 'phone': '+40751129600'}, {'name': 'GABRIELA STEFANESCU, PhD, Lecturer', 'role': 'CONTACT', 'email': 'gabriela.stefanescu@gmail.com', 'phone': '+40744244266'}], 'overallOfficials': [{'name': 'GHEORGHE BALAN, PhD, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': '"GRIGORE T. POPA" UNIVERSITY OF MEDICINE AND PHARMACY IAŞI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grigore T. Popa University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PhD Student', 'investigatorFullName': 'PAVEL LAURA', 'investigatorAffiliation': 'Grigore T. Popa University of Medicine and Pharmacy'}}}}