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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005258
Receipt No. R000006253
Scientific Title Usefulness of a new cytology devise for biliary stricture
Date of disclosure of the study information 2011/04/01
Last modified on 2011/09/18

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Basic information
Public title Usefulness of a new cytology devise for biliary stricture
Acronym A useful new cytology devise for biliary stricture
Scientific Title Usefulness of a new cytology devise for biliary stricture
Scientific Title:Acronym A useful new cytology devise for biliary stricture
Region
Japan

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

Objectives
Narrative objectives1 Feasibility of a new cytology devise for malignant biliary stricture
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1) Yields for adequate cytologic specimen sampling
Key secondary outcomes 1) Yields for adequate histologic spesimen sampling
2) Diagnostic accuracy
3) Complication rate

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 a conventional brush and following a new device (5 cases)
Interventions/Control_2 a new device and following a conventional brush(5 cases)
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) Patients in whom malignant biliary stricture is suspected.
2) Patients in whom endoscopic approach to biliary tract is difficult.
3) Patinets in whom written informed consent cannot be obtained.
Key exclusion criteria 1) Patients with poor general condition.
2) Bleeding tendancy
3) Patients with concominant severe illness.
4) Patients in whom doctors consider as improper.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shujiro Yazumi
Organization The Tazuke Kofukai Medical Reserch Institute Kitano Hospital
Division name Digestive Disease Center
Zip code
Address 2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL 06-6312-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shujiro Yazumi
Organization Kitano Hospital
Division name Digestive Disease Center
Zip code
Address 2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL 06-6312-1221
Homepage URL
Email s-yazumi@kitano-hp.or.jp

Sponsor
Institute The Tazuke Kofukai Medical Reserch Institute Kitano Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北野病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Accuracy of the new device is as same as that of cytology brush. However, the new device can obtain the tissue sample available for pathological examination in one thirds of the patients.
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 Completed
Date of protocol fixation
2010 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded
2011 Year 10 Month 01 Day

Other
Other related information The 47th annual meeting of the Japan Biliary association

Management information
Registered date
2011 Year 03 Month 16 Day
Last modified on
2011 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006253

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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