Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 6:31 PM
Study NCT ID:
NCT01859169
Status:
SUSPENDED
Last Update Posted:
2013-05-21
First Post:
2013-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}], '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': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Modifying the clinnicaltrials', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complication of therapy', 'timeFrame': 'one month'}], 'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bili duct neoplasms', 'bile duct cancer', 'photodynamic therapy', 'biliary drainage'], 'conditions': ['Cholangiocarcinoma']}, 'referencesModule': {'references': [{'pmid': '18255347', 'type': 'BACKGROUND', 'citation': 'Kahaleh M, Mishra R, Shami VM, Northup PG, Berg CL, Bashlor P, Jones P, Ellen K, Weiss GR, Brenin CM, Kurth BE, Rich TA, Adams RB, Yeaton P. Unresectable cholangiocarcinoma: comparison of survival in biliary stenting alone versus stenting with photodynamic therapy. Clin Gastroenterol Hepatol. 2008 Mar;6(3):290-7. doi: 10.1016/j.cgh.2007.12.004. Epub 2008 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with bile duct cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.\n\nExclusion Criteria:\n\n* 1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer'}, 'identificationModule': {'nctId': 'NCT01859169', 'briefTitle': 'Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Longterm Outcome of Photodynamic Therapy Compared With Biliary Drainage Alone in Patients With Unresectable Cholangiocarcinoma', 'orgStudyIdInfo': {'id': 'PDT-B-01'}, 'secondaryIdInfos': [{'id': 'PDT-B-01', 'type': 'OTHER', 'domain': 'Central South University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Group that be administrated biliary drainage only'}, {'label': 'PDT Group', 'description': 'Group that be administrated photodynamic therapy and biliary drainage', 'interventionNames': ['Procedure: Photodynamic therapy']}], 'interventions': [{'name': 'Photodynamic therapy', 'type': 'PROCEDURE', 'description': 'Each patient to whom PDT was offered underwent a specific, detailed educational process by a dedicated team member(P.B., P.J., or K.E.), after which informed consent was obtained.Porfimer sodium (Photofrin; Axcan Pharma Inc, Quebec, Canada)was used as a photo sensitizing agent, administered intravenously at a dose of 2 mg/kg body weight 48 hours before illumination.A diode laser system (InGaAIP Laser Diode; Diomed Inc, An-dover, MA) with a maximum power output of 2000 mW and a wavelength of 633+-3 nm was used as a light source, delivered through a 3.0-m length fiber having a 2.5-cm-long cylindrical diffuser at its distal end (Pioneer Optics, Windsor Locks, CT).', 'armGroupLabels': ['PDT Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410016', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'li xiong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor（visiting staff）', 'investigatorFullName': 'li xiong', 'investigatorAffiliation': 'Central South University'}}}}