Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT03057769
Status:
TERMINATED
Last Update Posted:
2017-10-27
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007213', 'term': 'Indomethacin'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3300}}, 'statusModule': {'whyStopped': 'This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Severity of PEP evaluated by updated Atlanta criteria', 'timeFrame': '30 days'}, {'measure': 'ERCP-related perforation', 'timeFrame': '30 days'}, {'measure': 'Biliary infection', 'timeFrame': '30 days'}, {'measure': 'Length of post-procedure hospital stay', 'timeFrame': '30 days'}, {'measure': 'Death', 'timeFrame': '30 days'}], 'primaryOutcomes': [{'measure': 'Overall post-ERCP pancreatitis (PEP)', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Moderate to severe PEP', 'timeFrame': '30 days'}, {'measure': 'Clinical significant gastrointestinal bleeding', 'timeFrame': '30 days'}, {'measure': 'Overall ERCP complications', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP, post-ERCP pancreatitis, indomethacin, epinephrine'], 'conditions': ['Pancreatitis', 'Endoscopic Retrograde Cholangiopancreatography']}, 'referencesModule': {'references': [{'pmid': '15173799', 'type': 'BACKGROUND', 'citation': 'Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.'}, {'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': '25973947', 'type': 'BACKGROUND', 'citation': 'Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.'}, {'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.'}, {'pmid': '23164513', 'type': 'BACKGROUND', 'citation': 'Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc. 2012 Dec;76(6):1152-9. doi: 10.1016/j.gie.2012.08.021.'}, {'pmid': '19159075', 'type': 'BACKGROUND', 'citation': 'Matsushita M, Takakuwa H, Shimeno N, Uchida K, Nishio A, Okazaki K. Epinephrine sprayed on the papilla for prevention of post-ERCP pancreatitis. J Gastroenterol. 2009;44(1):71-5. doi: 10.1007/s00535-008-2272-8. Epub 2009 Jan 22.'}, {'pmid': '9255527', 'type': 'BACKGROUND', 'citation': 'Tarnasky P, Cunningham J, Cotton P, Hoffman B, Palesch Y, Freeman J, Curry N, Hawes R. Pancreatic sphincter hypertension increases the risk of post-ERCP pancreatitis. Endoscopy. 1997 May;29(4):252-7. doi: 10.1055/s-2007-1004185.'}, {'pmid': '9378207', 'type': 'BACKGROUND', 'citation': 'Johnson GK, Geenen JE, Johanson JF, Sherman S, Hogan WJ, Cass O. Evaluation of post-ERCP pancreatitis: potential causes noted during controlled study of differing contrast media. Midwest Pancreaticobiliary Study Group. Gastrointest Endosc. 1997 Sep;46(3):217-22. doi: 10.1016/s0016-5107(97)70089-0.'}, {'pmid': '8574325', 'type': 'BACKGROUND', 'citation': 'Ohno T, Katori M, Nishiyama K, Saigenji K. Direct observation of microcirculation of the basal region of rat gastric mucosa. J Gastroenterol. 1995 Oct;30(5):557-64. doi: 10.1007/BF02367779.'}, {'pmid': '21392105', 'type': 'BACKGROUND', 'citation': 'Xu LH, Qian JB, Gu LG, Qiu JW, Ge ZM, Lu F, Wang YM, Li YM, Lu HS. Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by epinephrine sprayed on the papilla. J Gastroenterol Hepatol. 2011 Jul;26(7):1139-44. doi: 10.1111/j.1440-1746.2011.06718.x.'}, {'pmid': '27299638', 'type': 'BACKGROUND', 'citation': 'Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.'}, {'pmid': '23896955', 'type': 'BACKGROUND', 'citation': 'Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.'}, {'pmid': '24054878', 'type': 'BACKGROUND', 'citation': 'Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.'}, {'pmid': '30391434', 'type': 'DERIVED', 'citation': 'Luo H, Wang X, Zhang R, Liang S, Kang X, Zhang X, Lou Q, Xiong K, Yang J, Si L, Liu W, Liu Y, Zhou Y, Wang S, Yang M, Chen W, Han Y, Shang G, Yang X, He Y, Zou Q, Guo W, Dai Y, Zeng W, Zhu X, Gong R, Li X, Nie Z, Wang Q, Wang L, Pan Y, Guo X, Fan D. Rectal Indomethacin and Spraying of Duodenal Papilla With Epinephrine Increases Risk of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1597-1606.e5. doi: 10.1016/j.cgh.2018.10.043. Epub 2018 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. It accounts for substantial morbidity and represents a substantial cost to health-care systems. European Society of Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines and recently large-scale RCT recommended routine use of NSAIDs indomethacin rectally before ERCP. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to inhibit prostaglandin synthesis, phospholipase A2 activity, and neutrophil/endothelial cell attachment, which is believed to play a key role in the pathogenesis of acute pancreatitis.\n\nOther possible mechanisms have been suggested in the occurrence of pancreatitis. Papillary edema caused by manipulations during cannulation or endoscopic treatment has received the most attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. A meta-analysis (including 2 existing RCTs and post-hoc analysis of our previous study) of papillary epinephrine spraying compared with saline spraying or no intervention indicates a potential relative risk reduction of PEP (RR 0.34, 95%CI 0.19-0.61). Papillary epinephrine spraying may be an inexpensive and convenient alternative for prevention of post-ERCP pancreatitis. A large pragmatic RCT to determine whether routine using papillary epinephrine spraying can reduce post-ERCP pancreatitis is needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old patients planned for ERCP.\n\nExclusion Criteria:\n\n* contraindications to ERCP\n* allergy to epinephrine or NSAIDs\n* Not suitable for pre-ERCP indomethacin (received NSAIDs within 7 days before the procedure; gastrointestinal hemorrhage within 4 weeks; renal dysfunction \\[Cr \\>1.4mg/dl=120umol/l\\]; presence of coagulopathy before the procedure)\n* previous biliary sphincterotomy without planned pancreatic duct manipulation\n* ERCP for biliary stent removal or exchange without planned pancreatic duct manipulation\n* acute pancreatitis within 3 days before the procedure\n* unwilling or inability to provide consent\n* pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT03057769', 'briefTitle': 'Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin: A Multi-center, Double-blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KY20162097-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PES group', 'description': 'All patients in this group receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.', 'interventionNames': ['Drug: Papillary epinephrine spraying', 'Drug: Indomethacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'All patients in this group receive 20 ml of saline sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.', 'interventionNames': ['Drug: Papillary saline spraying', 'Drug: Indomethacin']}], 'interventions': [{'name': 'Papillary epinephrine spraying', 'type': 'DRUG', 'otherNames': ['PES'], 'description': 'All patients in this group receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.', 'armGroupLabels': ['PES group']}, {'name': 'Papillary saline spraying', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'All patients in this group receive 20 ml of saline sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.', 'armGroupLabels': ['Control group']}, {'name': 'Indomethacin', 'type': 'DRUG', 'description': 'All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.', 'armGroupLabels': ['Control group', 'PES group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Department of Gastroenterology, Successful Hospital of Xiamen university', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '361004', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Department of Gastroenterology, Zhongshan Hospital of Xiamen university', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Department of General Surgery, The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '725000', 'city': 'Ankang', 'state': 'Shaanxi', 'country': 'China', 'facility': 'Endoscopy Center, Ankang Central Hospital', 'geoPoint': {'lat': 32.68, 'lon': 109.01722}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710068', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Department of Gastroenterology, No. 451 Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '832008', 'city': 'Shihezi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University', 'geoPoint': {'lat': 44.3023, 'lon': 86.03694}}, {'zip': '830000', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Department of Gastroenterology, Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '750004', 'city': 'Yinchuan', 'country': 'China', 'facility': 'Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Yanglin Pan', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}