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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033652
Receipt No. R000038368
Official scientific title of the study A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases
Date of disclosure of the study information 2018/08/07
Last modified on 2018/08/07

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Basic information
Official scientific title of the study A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases
Title of the study (Brief title) A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases
Region
Japan

Condition
Condition cholangiocarcinoma benign biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of EUS-FNA and ERCP for diagnosing biliary tract disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate diagnostic performances of EUS-FNA and ERCP tissue sampling based on pathological evaluation.
Key secondary outcomes To evaluate the adverse events of EUS-FNA, ERCP for biliary tract disease.
To evaluate the factors related to accuracy of EUS-FNA, ERCP tissue sampling for biliary tract cancer.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Men and women aged 20 years or older at the time of performing the endoscopic procedure.
Patients who underwent pathologic diagnosis for biliary tract mass and / or bile duct stricture.
Key exclusion criteria Patients who were refused to participate in the opt-out poster.
Patients recieved medication for malignant tumor within 1 month prior to acquiring the pathological specimen.
Patients whom researcher considered inappropriate.
Target sample size 75

Research contact person
Name of lead principal investigator Takumi Onoyama
Organization Faculty of Medicine, Tottori University
Division name Department of Multidisciplinary Internal Medicine, Division of Medicine and Clinical Science
Address 36-1 Nishi-cho, Yonago
TEL 0859-38-6527
Email golf4to@yahoo.co.jp

Public contact
Name of contact person Takumi Onoyama
Organization Faculty of Medicine, Tottori University
Division name Department of Multidisciplinary Internal Medicine, Division of Medicine and Clinical Science
Address 36-1 Nishi-cho, Yonago
TEL 0859-38-6527
Homepage URL
Email golf4to@yahoo.co.jp

Sponsor
Institute Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Faculty of Medicine, Tottori University
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 07 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 12 Month 28 Day
Anticipated trial start date
2018 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Case control study
between October 2011 and March 2017.
sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of endoscopic tissue sampling.
adverse event of endoscopic tissue sampling.

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038368

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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