Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT05233293
Status:
UNKNOWN
Last Update Posted:
2023-08-15
First Post:
2022-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-02-05', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological positive rate', 'timeFrame': '1 month', 'description': 'Malignant tumor diagnosis rate'}, {'measure': 'complications', 'timeFrame': '1 month', 'description': 'Incidence of Postoperative complications such as bleeding and infection'}], 'secondaryOutcomes': [{'measure': 'Number of sessions', 'timeFrame': '1 month', 'description': 'Number of ERCP and RFA procedures'}, {'measure': 'Procedure Time', 'timeFrame': 'Intraoperative', 'description': 'Time spent for each surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spyglass', 'RFA', 'extrahepatic cholangiocarcinoma', 'ERCP'], 'conditions': ['Extrahepatic Cholangiocarcinoma', 'Malignant Biliary Obstruction']}, 'referencesModule': {'references': [{'pmid': '33631748', 'type': 'BACKGROUND', 'citation': 'Weigand K, Kuchle M, Zuber-Jerger I, Muller M, Kandulski A. Diagnostic Accuracy and Therapeutic Efficacy of Digital Single-Operator Cholangioscopy for Biliary Lesions and Stenosis. Digestion. 2021;102(5):776-782. doi: 10.1159/000513713. Epub 2021 Feb 25.'}, {'pmid': '33921514', 'type': 'BACKGROUND', 'citation': 'Minami H, Mukai S, Sofuni A, Tsuchiya T, Ishii K, Tanaka R, Tonozuka R, Honjo M, Yamamoto K, Nagai K, Matsunami Y, Asai Y, Kurosawa T, Kojima H, Homma T, Itoi T. Clinical Outcomes of Digital Cholangioscopy-Guided Procedures for the Diagnosis of Biliary Strictures and Treatment of Difficult Bile Duct Stones: A Single-Center Large Cohort Study. J Clin Med. 2021 Apr 12;10(8):1638. doi: 10.3390/jcm10081638.'}]}, 'descriptionModule': {'briefSummary': 'With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time.The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.', 'detailedDescription': 'Endoscopic retrograde cholangiopancreatography (ERCP) has been used as the primary method for the diagnosis of biliary strictures and the treatment of extrahepatic cholangiocarcinoma. However, the accurate visual diagnosis of malignant biliary strictures and assessment of the extent of a lesion are not possible by ERCP, and treatment of extrahepatic cholangiocarcinoma by ERCP procedures is sometimes difficult. In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time. Spyglass enables direct visualization of the biliary tract and the sampling of suspicious lesions, together with radiofrequency ablation.Endoscopic radiofrequency ablation (RFA) is an emerging technique for the palliation of inoperable malignant biliary strictures (MBSs). In a dozen published studies, this novel approach has shown better safety and feasibility, as well as improvement in overall survival (OS). The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years ;\n* Patients with high suspicion of extrahepatic cholangiocarcinoma such as unexplained bile duct stenosis or elevated CA19-9 were found according to relevant imaging studies or symptoms;\n* Willing to abide by the research procedures and sign the informed consent.\n\nExclusion Criteria:\n\n* Myocardial infarction within 3 months;\n* Renal insufficiency (Scr\\>177 umol/L);\n* Serious cardiovascular and cerebrovascular or respiratory diseases before surgery;\n* Preoperative shock manifestations, such as hypotension ( Systolic blood pressure \\<90mmHg) or increased heart rate (\\>120 beats/min);\n* Pregnancy and lactation;\n* Allergic to NSAIDs; Other clinical observation trials or those who have participated in other clinical trials within 60 days;\n* Cases deemed inappropriate by the investigator (such as those with clear contraindications to ERCP).'}, 'identificationModule': {'nctId': 'NCT05233293', 'briefTitle': 'Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma', 'orgStudyIdInfo': {'id': '2022-01-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SpyGlass group', 'description': 'ERCP plus SpyGlass plus RFA group', 'interventionNames': ['Procedure: Spyglass + RFA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cytobrush Group', 'description': 'ERCP plus Cytobrush plus RFA group', 'interventionNames': ['Procedure: Cytobrush + RFA']}], 'interventions': [{'name': 'Spyglass + RFA', 'type': 'PROCEDURE', 'description': 'SpyGlass direct Vision guided RFA', 'armGroupLabels': ['SpyGlass group']}, {'name': 'Cytobrush + RFA', 'type': 'PROCEDURE', 'description': 'After Cytobrush ,taking RFA through ERCP', 'armGroupLabels': ['Cytobrush Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Jianfeng Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Hangzhou"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jianfeng Yang', 'investigatorAffiliation': "First People's Hospital of Hangzhou"}}}}