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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042435
Receipt No. R000048444
Scientific Title Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/12

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Basic information
Public title Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Acronym Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Scientific Title Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Scientific Title:Acronym Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Region
Japan

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

Objectives
Narrative objectives1 evaluate additional effect of peroral cholangioscope to computed tomography on diagnosis of biliary strictures and tumor spread
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in agreement between the evaluation of CT and ERCP images and that with POCSadded to the final diagnosis
Key secondary outcomes

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 1) A case in which biliary stricture was diagnosed by dynamic CT and ERCP was performed at our hospital for the purpose of benign / malignant diagnosis or tumor spread
2) performing a four-phase CT without pneumobilia and biliary stent.
3) using video cholangioscope.
4) performing CT and POCS within sixty days.
Key exclusion criteria 1) pancreatic disease and tumor of duodenal papilla diagnosed without POCS.
2) patients who did not undergo radical resection or were treated before surgery for malignant disease.
3) patients who underwent follow-up of less than three years for benign disease.
4) anastomotic stricture diagnosed with medical history.
5) biliary strictures by primary hepatic cancer and metastatic tumor.
6) pancreaticobiliary maljunction without findings to suggest malignancy.
7) A case in which there was an offer to refuse participation in this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Kato
Organization Graduate School of Medicine, Chiba University
Division name Department of Gastroenterology
Zip code 260-8677
Address Inohana 1-8-1, Chiba-City, Japan.
TEL 043-222-7171
Email kato.naoya@chiba-u.jp

Public contact
Name of contact person
1st name Yukiko
Middle name
Last name Shima
Organization Graduate School of Medicine, Chiba University
Division name Department of Gastroenterology
Zip code 260-8677
Address Inohana 1-8-1, Chiba-City, Japan.
TEL 043-222-7171
Homepage URL
Email shimako1029@gmail.com

Sponsor
Institute Department of Gastroenterology, Graduate School of Medicine, Chiba University.
Institute
Department

Funding Source
Organization Department of Gastroenterology, Graduate School of Medicine, Chiba University.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chiba University Certified Review Board
Address Inohana 1-8-1, Chiba-City, Japan.
Tel 043-222-7171
Email igaku-rinri@office.chiba-u.jp

Secondary IDs
Secondary IDs YES
Study ID_1 3608
Org. issuing International ID_1 Chiba University Certified Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 13 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 52
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 No longer recruiting
Date of protocol fixation
2019 Year 11 Month 27 Day
Date of IRB
2019 Year 12 Month 24 Day
Anticipated trial start date
2019 Year 12 Month 25 Day
Last follow-up date
2020 Year 09 Month 09 Day
Date of closure to data entry
2020 Year 09 Month 09 Day
Date trial data considered complete
2020 Year 09 Month 09 Day
Date analysis concluded

Other
Other related information This research is retrospective cohort study.

Management information
Registered date
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048444

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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