Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-09 @ 1:57 AM
Study NCT ID:
NCT04242394
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
If Chronic Gallbladder Diseases Increase the Incidence of PEC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1019}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Acute PEC(post-ERCP-cholecystitis )', 'timeFrame': '1month', 'description': 'When the PEC occurs, with right upper abdominal pain, White Blood Cell increasing, gallbladder wall ≥4mm or crudely, temperature might be more than 38 degree centigrade'}], 'secondaryOutcomes': [{'measure': 'Number of Pancreatitis', 'timeFrame': '1month', 'description': 'Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.'}, {'measure': 'Number of Cholangitis', 'timeFrame': '1 month', 'description': 'Temperature should be more than 38 #, right upper abdominal pain, chills or WBC≥10'}, {'measure': 'Number of Perforation', 'timeFrame': '1 month', 'description': 'Typical abdominal pain,abdominal muscle tension, tenderness, evidence of free gas in abdominal cavity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'Acute purulent cholecystitis', 'Bile duct stone', 'Post-ERCP-Choledocholithiasis PEC'], 'conditions': ['Cholecystitis']}, 'referencesModule': {'references': [{'pmid': '31382888', 'type': 'BACKGROUND', 'citation': 'Cao J, Ding X, Wu H, Shen Y, Zheng R, Peng C, Wang L, Zou X. Classification of the cystic duct patterns and endoscopic transpapillary cannulation of the gallbladder to prevent post-ERCP cholecystitis. BMC Gastroenterol. 2019 Aug 5;19(1):139. doi: 10.1186/s12876-019-1053-6.'}, {'pmid': '30134864', 'type': 'BACKGROUND', 'citation': 'Cao J, Peng C, Ding X, Shen Y, Wu H, Zheng R, Wang L, Zou X. Risk factors for post-ERCP cholecystitis: a single-center retrospective study. BMC Gastroenterol. 2018 Aug 22;18(1):128. doi: 10.1186/s12876-018-0854-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC)', 'detailedDescription': 'Endoscopic Retrograde Choledochopancreatography(ERCP) has the advantages of less injury and faster recovery for common bile duct stone patients. However, according to our retrospective study, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis which often requires emergency intervention, when patients combined with chronic gallbladder diseases, such as chronic cholecystitis, asymptomatic gallstones, and gallbladder wall thickness, the incidence of PEC will increase accordingly. The aim of this study is to observe if chronic gallbladder disease will increase the occurence of PEC and develop a high-risk PEC model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Common bile duct stone ERCP patients with gallbladder in situ', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ERCP patients with gallbladder in situ\n\nExclusion Criteria:\n\n* Acute cholecystitis before surgery\n* Gallbladder has been removed\n* Gastrointestinal reconstruction\n* Unwillingness or inability to consent for the study\n* Unstable vital signs Coagulation dysfunction (INR\\>1.5)\n* Low peripheral blood platelet count (\\<50×10 \\^9 / L) or using anti-coagulation drugs\n* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock Biliary- duodenal fistula confirmed during ERCP\n* Pregnant women or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04242394', 'briefTitle': 'If Chronic Gallbladder Diseases Increase the Incidence of PEC', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis（a Prospective Multi-center Cohort Study)', 'orgStudyIdInfo': {'id': 'Chronic gallbladder disease'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic gallbladder diseases', 'description': 'Routine ERCP participants with chronic gallbladder diseases', 'interventionNames': ['Procedure: ERCP']}, {'label': 'Without Chronic gallbladder disease', 'description': 'Routine ERCP participants without chronic gallbladder diseases', 'interventionNames': ['Procedure: ERCP']}], 'interventions': [{'name': 'ERCP', 'type': 'PROCEDURE', 'description': 'Routine ERCP procedures with gallbladder in situ patient', 'armGroupLabels': ['Chronic gallbladder diseases', 'Without Chronic gallbladder disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '746000', 'city': 'Longnan', 'state': 'Gansu', 'country': 'China', 'facility': 'Chinese herb medicine hospital of Longnan City', 'geoPoint': {'lat': 33.39791, 'lon': 104.91703}}, {'zip': '741000', 'city': 'Tianshui', 'state': 'Gansu', 'country': 'China', 'facility': 'The first hospital of Tianshui', 'geoPoint': {'lat': 34.57952, 'lon': 105.74238}}, {'zip': '733000', 'city': 'Wuwei', 'state': 'Gansu', 'country': 'China', 'facility': 'Wuwei turmour hospital', 'geoPoint': {'lat': 37.92672, 'lon': 102.63202}}], 'overallOfficials': [{'name': 'Wenbo Meng, M.D., Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph. D, Direct of surgery', 'investigatorFullName': 'Wenbo Meng', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}