Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-04-23 @ 12:44 PM
Study NCT ID:
NCT03104569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2017-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D018285', 'term': 'Klatskin Tumor'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2017-03-26', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Acute cholangitis', 'timeFrame': '2 weeks', 'description': 'Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks'}], 'secondaryOutcomes': [{'measure': 'The ease of injection', 'timeFrame': 'During procedures', 'description': 'The ease of contrast agent injection has been considered by ERCP assistant, a questionnaire is required to assign by the assistant'}, {'measure': 'Number of Participants With Abnormal Laboratory Values', 'timeFrame': '4 days', 'description': '9 parameter will be collected in day 2 and day 4 after procedures. Abnormal in Total bilirubin (TBIL), White Blood Count (WBC), N%,Platelet( PLT), Procalcitonin(PCT) or C-reactive protein(CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and Gamma - glutamyl transpeptidase (GGT) required to be documented'}, {'measure': 'Operation time', 'timeFrame': 'intraoperative', 'description': 'Total time of procedure'}, {'measure': 'X-ray exposure time', 'timeFrame': 'intraoperative', 'description': 'The total time of X-ray exposure'}, {'measure': 'Number of participants with Post-ERCP pancreatitis', 'timeFrame': '1 months', 'description': 'Post-ERCP pancreatitis is defined if patients experienced abdominal pain for more than 24h after ERCP, accompanying with amylase or lipase more than 3 times equal to the upper limit of normal value.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'Contrast agent', 'Hilar cholangiocarcinoma', 'Cholangitis', 'Nonionic'], 'conditions': ['Cholangitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.', 'detailedDescription': "At present, the common used contrast agent in ERCP is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. When heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. And the applications of heated non-ionic contrast agents could be found in computed tomography angiography(CTA), hysterosalpingography (HSG) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. Nevertheless, heated contrast agent was rarely reported to act in ERCP. It's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;\n* Age: 18\\~90 years old;\n* Underwent diagnostic and therapeutic ERCP;\n\nExclusion Criteria:\n\n* Coagulation dysfunction(INR\\>1.3) or/and low peripheral blood platelet count （PLT \\<50x10\\^9/L）;\n* Preoperative acute cholangitis;\n* Preoperative acute pancreatitis;\n* Preoperative hemobilia or hemorrhage of digestive tract;\n* Preoperative liver failure;\n* Combined with Mirizzi syndrome and intrahepatic bile duct stones;\n* Preoperative malignant tumor of biliary system such as carcinoma of head of pancreas, gallbladder carcinoma;\n* Biliary-duodenal fistula confirmed during ERCP;\n* A history of reconstructive surgery for upper digestive tract except Billroth Ⅰand a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum;\n* Previous ERCP;\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03104569', 'briefTitle': 'Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': '37℃ Contrast Agent in ERCP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injection of 37℃ contrast agent', 'description': 'Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent', 'interventionNames': ['Procedure: Injection of 37℃ contrast agent']}, {'type': 'NO_INTERVENTION', 'label': 'Injection of normal contrast agent', 'description': 'Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent'}], 'interventions': [{'name': 'Injection of 37℃ contrast agent', 'type': 'PROCEDURE', 'description': 'Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent', 'armGroupLabels': ['Injection of 37℃ contrast agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'contacts': [{'name': 'Wence Zhou, M. D.', 'role': 'CONTACT', 'email': 'zhouwc129@163.com', 'phone': '+8609318356919'}, {'name': 'Wenbo Meng, M. D.', 'role': 'CONTACT', 'email': 'mengwb@lzu.edu.cn', 'phone': '+8609318356213'}], 'facility': 'The first hospital of Lanzhou university', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'Hao Sun, M. D.', 'role': 'CONTACT', 'email': 'sunhaoxjfy@126.com', 'phone': '+86 13891813691'}], 'facility': "The first affiliated hospital of Xi 'an jiaotong university", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '300100', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Zhenyu Wang, M. D.', 'role': 'CONTACT', 'email': 'Wangzytj@163.com', 'phone': '+86 15302021661'}], 'facility': 'Tianjin Nankai Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Wenbo Meng, M.D., Ph. D.', 'role': 'CONTACT', 'email': 'mengwb@lzu.edu.cn', 'phone': '+8613919177177'}, {'name': 'Xun Li, M.D., Ph. D.', 'role': 'CONTACT', 'email': 'drlixun@163.com', 'phone': '+8613993138612'}], 'overallOfficials': [{'name': 'Xun Li, M.D., Ph. D.', 'role': 'STUDY_CHAIR', '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, Director.', 'investigatorFullName': 'Xun Li', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}