UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026929 |
|---|---|
| Receipt number | R000030453 |
| Scientific Title | Effectiveness of bile cytology using endoscopic transpapillary gallbladder drainage to distinguish gallbladder cancers from benign gallbladder diseases. -a prospective multicenter observational study- |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2020/10/12 16:23:37 |
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Basic information
Public title
Effectiveness of bile cytology using endoscopic transpapillary gallbladder drainage to distinguish gallbladder cancers from benign gallbladder diseases. -a prospective multicenter observational study-
Acronym
Effectiveness of ETGD for diagnosis of gallbladder diseases
Scientific Title
Effectiveness of bile cytology using endoscopic transpapillary gallbladder drainage to distinguish gallbladder cancers from benign gallbladder diseases. -a prospective multicenter observational study-
Scientific Title:Acronym
Effectiveness of ETGD for diagnosis of gallbladder diseases
Region
| Japan |
Condition
Condition
Gallbladder disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the efficacy of endoscopic transpapillary gallbladder drainage to distinguish gallbladder cancers from benign gallbladder diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of cytology
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
Patients who are difficult to distinguish gallbladder cancers from benign gallbladder diseases by imaging modalities
Key exclusion criteria
1) Patients with performance status 4.
2) Patients who have severe disease
3) Presence of apparent cancer infiltration of the liver, stenosis of common bile duct and distant metastasis
4) Age<20
5) Patients without informed concern.
6) Patients who are judged inappropriate by chief medical examiner.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomoda |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
tomotake79@yahoo.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Department of Gastroenterology & Hepatology
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
Research design: prospective multicenter observational study
Recruiting methods of objects: all the patients who conform to the criteria visiting to Okayama University Hospital and 3 hospitals affilitated to Okayama University between May 2017 and May 2020.
Evaluation item: diagnostic accuracy of bile cytology, CT images, and MRI images, success rate of ETGD procedures, investigate the required number of bile cytology to diagnose gallbladder cancer, complications from ETGD procedures
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030453
