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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040844
Receipt No. R000046633
Scientific Title Comparison of diagnostic sensitivity of peroral cholangioscopy-guided target biopsy with that of transpapillary forceps biopsy under fluoroscopic guidance in patients suspected with bile duct cancer: A multicenter retrospective cohort study
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/21

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Basic information
Public title Comparison of diagnostic sensitivity of peroral cholangioscopy-guided target biopsy with that of transpapillary forceps biopsy under fluoroscopic guidance in patients suspected with bile duct cancer: A multicenter retrospective cohort study
Acronym POCS- vs ERCP-guided biopsy
Scientific Title Comparison of diagnostic sensitivity of peroral cholangioscopy-guided target biopsy with that of transpapillary forceps biopsy under fluoroscopic guidance in patients suspected with bile duct cancer: A multicenter retrospective cohort study
Scientific Title:Acronym POCS- vs ERCP-guided biopsy
Region
Japan

Condition
Condition bile duct cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the diagnostic ability of peroral cholangioscopy-guided target biopsy for biliary stricture suspected with bile duct cancer by comparing that of conventional endoscopic transpapillary forceps biopsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic sensitivity
Key secondary outcomes accuracy, specificity, positive predictive value (PPV), negative predictive value (NPV), sample size, and sample quality

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients suspected with bile duct cancer who underwent biopsy under both fluoroscopy and cholangioscopy guidance in same session at University of Toyama,Gifu University, and Teikyo University Mizonokuchi Hospital between November 2013 and February 2020.
Key exclusion criteria 1. Patients with pancreatic head mass and with dialation of upstream main pancreatic duct
2. Patients with exposure of tumor at duodenal papilla
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Yasuda
Organization University of Toyama
Division name Third Department of Internal Medicine
Zip code 930-0194
Address 2630 Sugitani, Toyama
TEL 076-434-7300
Email yasudaic@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Ichiro
Middle name
Last name Yasuda
Organization University of Toyama
Division name Third Department of Internal Medicine
Zip code 930-0194
Address 2630 Sugitani, Toyama
TEL 076-434-7300
Homepage URL
Email yasudaic@med.u-toyama.ac.jp

Sponsor
Institute Third Department of Internal Medicine, University of Toyama
Institute
Department

Funding Source
Organization Third Department of Internal Medicine, University of Toyama
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor First Department of Internal Medicine, Gifu University Hospital and Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for Clinical Reserch in Toyama University Hospital
Address 2630 Sugitani, Toyama 930-0194
Tel 076-415-8857
Email rinri@adm.u-toyama.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 富山大学附属病院(富山県)、岐阜大学医学部附属病院(岐阜県)、帝京大学溝口病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 05 Month 11 Day
Date of IRB
2020 Year 06 Month 12 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 06 Month 21 Day
Last modified on
2020 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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