UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020192 |
|---|---|
| Receipt number | R000023320 |
| Scientific Title | The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures |
| Date of disclosure of the study information | 2017/01/07 |
| Last modified on | 2017/01/07 14:03:15 |
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Basic information
Public title
The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Acronym
The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Scientific Title
The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Scientific Title:Acronym
The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Region
| Asia(except Japan) |
Condition
Condition
Malignant biliary stricture
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the diagnostic yields of IDUS-guided transpapillary bile duct biopsy compared with fluoroscopy-guided biopsy in patients with suspected MBS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the accuracy of the IDUS-guided TPB and fluoroscopy-guided TPB in patients with suspected MBS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
IDUS guided transpapillary bile duct biopsy
Interventions/Control_2
Fluoroscopically guided transpapillary bile duct biopsy
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
| 18 | years-old | < |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) clinical presentation that consistent with a biliary stricture (e.g., jaundice), (2) evidence of biliary stricture on imaging studies, including abdominal ultrasonography (US) and/or computed tomography (CT), (3) the diameter of the common bile duct (CBD) of 8 mm or more, (4) age older than 18 years and (5) ability to provide informed consent
Key exclusion criteria
1) diagnosed as definite benign disease by routine examinations including abdominal US and CT, (2) lesions invading periampullary area, (3) history of previous biliary surgery except cholecystectomy, and (4) the presence of any contraindication to ERCP
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jong Ho Moon |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL
+82-32-621-5094
jhmoon@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yun Nah Lee |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL
+82-32-621-5094
Homepage URL
yunnah@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
SoonChunHyang University School of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 01 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 14 | Day |
Last modified on
| 2017 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023320
