UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005983 |
|---|---|
| Receipt number | R000007076 |
| Scientific Title | Formalize and improve the accuracy of preoperative biliary cytology in cholangiocarcinoma |
| Date of disclosure of the study information | 2011/07/15 |
| Last modified on | 2011/07/15 18:13:27 |
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Basic information
Public title
Formalize and improve the accuracy of preoperative biliary cytology in cholangiocarcinoma
Acronym
Formalize and improve the accuracy of bile cytology
Scientific Title
Formalize and improve the accuracy of preoperative biliary cytology in cholangiocarcinoma
Scientific Title:Acronym
Formalize and improve the accuracy of bile cytology
Region
| Japan |
Condition
Condition
Cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Formalize and improve the accuracy of bile cytology in the preoperative bile duct cancer bile cytology be repeated
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10 times to collect bile cytology. How the collection of group A (once daily for 10 days) and group B (five times a day for two days) is evaluated separately. Including assessing prevalence
Key secondary outcomes
Protein in bile, specifically those with elevated molecular markers to analyze and discuss whether there is a high accuracy over cytology
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Divided into group A and group B patients with bile cytology performed preoperatively. In group A, performed daily for 10 days once daily bile cytology.
Interventions/Control_2
Divided into group A and group B patients with bile cytology performed preoperatively. In group B, two days cytology performed five times a day.
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
Getting a diagnosis of bile duct cancer, reducing drainage tube for jaundice (PTBD or ENBD) insertion in patients.
Key exclusion criteria
Patient consent is not obtained from the patient or family.
Patients were deemed unsuitable to participate in the trial division of the study physician or the physician responsible for examination.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2222
Homepage URL
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 15 | 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
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 15 | Day |
Last modified on
| 2011 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007076
