Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-28 @ 4:17 AM
Study NCT ID:
NCT02882451
Status:
UNKNOWN
Last Update Posted:
2017-06-12
First Post:
2016-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C013199', 'term': 'pinaverium'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cannulation time for deep bile duct cannulation and pancreatic duct cannulation', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'bile juice flow from the major papilla and pancreatic juice flow from the major papilla', 'timeFrame': '2 days'}, {'measure': 'appearance of the major papillary orifice', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bile duct', 'endoscopic retrograde cholangiopancreatography', 'pinaverium bromide'], 'conditions': ['Bile Duct Diseases']}, 'descriptionModule': {'briefSummary': 'Pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (IBS) and functional disorders of the biliary tract. In this study, pinaverium bromide was compared with Vitamin C for the facilitation of bile duct and pancreatic duct cannulation in patients. The primary outcome was successful deep bile duct cannulation and pancreatic duct canulation. The second outcome was the major papillary orifice,bile juice flow from the papilla, time to achieve deep bile duct cannulation, fluoroscopy time for deep bile duct cannulation,the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the pinaverium bromide group versus Vitamin C group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. those with intact native papilla,\n2. who underwent endoscopic retrograde choledochopancreatography for bile duct,\n3. age≥18 years, ≤80years, and\n4. agreement to participate in the study.\n\nExclusion Criteria:\n\n1. a previous sphincterotomy,\n2. previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation,\n3. indwelling biliary or pancreatic stent(s),\n4. active acute pancreatitis,\n5. active acute pancreatitis\n6. altered/postsurgical anatomy,\n7. history of gastroparesis,\n8. endoscopic retrograde choledochopancreatography for sphincter of Oddi's sphincter(SO) manometry,\n9. known tumor of the major duodenal papilla, and\n10. patients with any medication probably affecting SO motility"}, 'identificationModule': {'nctId': 'NCT02882451', 'briefTitle': 'Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'orgStudyIdInfo': {'id': 'ERCP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pinaverium bromide', 'description': 'take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally', 'interventionNames': ['Dietary Supplement: pinaverium bromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vitamin C', 'description': 'take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally', 'interventionNames': ['Dietary Supplement: Vitamin C']}], 'interventions': [{'name': 'pinaverium bromide', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['pinaverium bromide']}, {'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Vitamin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhaoshen Li, MD', 'role': 'CONTACT', 'email': 'zhaoshenlismmu@gmail.com', 'phone': '86-21-81873241'}, {'name': 'zhaoshen Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changhai Hospital, Second Military Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shu-Ling Wang, M.D', 'role': 'CONTACT', 'email': 'wangshuling0000@126.com', 'phone': '021-81873241'}, {'name': 'Yu Bai, M.D', 'role': 'CONTACT', 'email': 'baiyu1998@hotmail.com', 'phone': '021-81873241'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Digestive Endoscopy Center', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}