UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005258 |
|---|---|
| Receipt number | 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 17:50:13 |
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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
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
s-yazumi@kitano-hp.or.jp
Sponsor or person
Institute
The Tazuke Kofukai Medical Reserch Institute Kitano Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006253
