UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009895 |
|---|---|
| Receipt number | R000011478 |
| Scientific Title | Efficacy of a newly designed biliary cytology brush for malignant biliary stricture |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2016/09/30 22:22:25 |
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Basic information
Public title
Efficacy of a newly designed biliary cytology brush for malignant biliary stricture
Acronym
New biliary device study
Scientific Title
Efficacy of a newly designed biliary cytology brush for malignant biliary stricture
Scientific Title:Acronym
New biliary device study
Region
| Japan |
Condition
Condition
Malignant biliary strictures
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate that diagnostic ratio of malignant biliary stricture is improved by using the newly designed cytology brush after biopsy forceps.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Difference of sensitivity and specificity between the newly designed cytology brush after using biopsy forceps and biopsy forceps alone.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The new device is used after a biopsy forceps during ERCP in cases of malignant biliary stricture.
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
1. Malignant biliary stricture is suspected.
2. The patient in whom ERCP can be done by a side-viewing endscope via ampulla of Vater .
3. The patients in whom written infomed consent is obtained.
Key exclusion criteria
1. Performance status 4.
2. ASA physical status is more than 3.
3. Judged as inadequate for this study by the investigator.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shujiro Yazumi |
Organization
The Tazuke Kofukai medical research institute Kitano Hospital
Division name
Division of gastroenterology and hepatology Digestive disease center
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
06-6312-1221
s-yazumi@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yojiro Sakuma |
Organization
Kyoto University
Division name
Faculty of medicine
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-4319
Homepage URL
yojiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
The Tazuke Kofukai medical research institute Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
The Tazuke Kofukai medical research institute Kitano Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gastroenterology and Hepatology, Graduate school of medicine, Kyoto University
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
Kyoto university hospital (Kyoto), Kitano hospital (Osaka) and Kyoto university related hospitals (Shizuoka, Shiga, Nara, Kyoto, Osaka, Wakayama, Hyogo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | 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
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
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 29 | Day |
Last modified on
| 2016 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011478
