Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-04-22 @ 5:02 AM
Study NCT ID:
NCT03211169
Status:
TERMINATED
Last Update Posted:
2019-11-08
First Post:
2017-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized prospective study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Inadequate enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen', 'timeFrame': '1 week', 'description': 'Malignancy or no malignancy diagnosis obtained from stricture biopsy'}], 'secondaryOutcomes': [{'measure': 'Cost', 'timeFrame': '2 years', 'description': 'Cumulative $ from devices used and facility fees with each approach'}, {'measure': 'Radiation Exposure', 'timeFrame': '2 years', 'description': 'Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings'}, {'measure': 'Procedure Duration', 'timeFrame': '2 years', 'description': 'in minutes'}, {'measure': 'Latency to diagnosis', 'timeFrame': '2 years', 'description': 'Duration in days from initial procedure to diagnosis of benign or malignant stricture'}, {'measure': 'Adverse Events', 'timeFrame': '2 weeks', 'description': '(Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholangiocarcinoma', 'Stricture; Bile Duct']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass\n2. All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass\n3. All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture\n4. Expected patient survival of at least 90 days\n5. High likelihood of patient follow-up\n6. Patient is able to give a written informed consent\n7. Patient is willing and able to comply with the study procedures\n\nExclusion Criteria:\n\n1. Patients with imaging suggestive of pancreatic tumor\n2. Children \\< 18 years of age\n3. Pregnant women\n4. Patients with impaired decision-making\n5. Healthy volunteers\n6. Primary Sclerosing Cholangitis (PSC)\n7. Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation\n8. Patients with any contraindication to endoscopic procedure\n9. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit\n10. Patients unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03211169', 'briefTitle': 'Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures', 'orgStudyIdInfo': {'id': '40988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric Biopsy Forceps directed biopsies', 'description': 'Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.', 'interventionNames': ['Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cholangioscopy-directed biopsies', 'description': 'Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.', 'interventionNames': ['Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies']}], 'interventions': [{'name': 'Biopsies of bile duct stricture with pediatric biopsy forceps', 'type': 'PROCEDURE', 'description': 'Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps', 'armGroupLabels': ['Pediatric Biopsy Forceps directed biopsies']}, {'name': 'Biopsies of bile duct stricture with cholangioscopy-directed biopsies', 'type': 'PROCEDURE', 'description': 'Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies', 'armGroupLabels': ['Cholangioscopy-directed biopsies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Rochester', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Division of Gastroenterology', 'investigatorFullName': 'Subhas Banerjee', 'investigatorAffiliation': 'Stanford University'}}}}