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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026929
Receipt No. 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

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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
Email 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
Email tomotake79@yahoo.co.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Department of Gastroenterology & Hepatology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030453

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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