UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016886 |
|---|---|
| Receipt number | R000019187 |
| Scientific Title | Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture |
| Date of disclosure of the study information | 2015/03/23 |
| Last modified on | 2016/07/19 19:30:33 |
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Basic information
Public title
Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Acronym
Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Scientific Title
Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Scientific Title:Acronym
Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Region
| Asia(except Japan) |
Condition
Condition
Malignant bile duct stricture
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluate the usefulness of a diagnostic approach using ERCP-guided transpapillary forceps biopsy (TPB) or EUS-guided fine needle aspiration biopsy (EUS-FNAB) according to the characteristics of the strictured segment in patients with suspected MBS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
the accuracy of the diagnostic approach using ERCP-guided TPB and EUS-FNAB according to the type of biliary stricture in patients with suspected MBS
Key secondary outcomes
the accuracy of initial TPB, technical failure and adverse event rates of ERCP-guided TPB and EUS-FNAB
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
EUS-guided fine-needle aspiration biopsy
Interventions/Control_2
Transpapillary forceps 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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) the presence of biliary stricture due to a thickened bile duct wall or pancreatobiliary mass revealed by cross-sectional radiologic images, computed tomography (CT), and/or magnetic resonance imaging (MRI), (2) clinical findings of obstructive jaundice and/or cholangitis, (3) age >18 years, and (4) ability to provide informed consent.
Key exclusion criteria
(1) underlying pancreatobiliary disease without clinical findings suggestive of malignancy (e.g., primary biliary cirrhosis or postoperative biliary stricture), (2) the presence of any contraindication for ERCP, (3) coagulopathy (international normalized ratio >1.5 or platelet count <80,000/mm3 (4) difficulty to perform ERCP due to altered gastrointestinal anatomy or a significant duodenal obstruction.
Target sample size
174
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jong Ho Moon |
Organization
Digestive Disease Center and Research Institute, Department of Internal Medicine, Soon Chun Hyang University School of Medicine
Division name
Gastroenterology
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 | Hyun Jong Choi |
Organization
Department of Internal Medicine, Soon Chun Hyang University School of Medicine
Division name
Gastroenterology
Zip code
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL
+82-32-621-5094
Homepage URL
joseph@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University
Institute
Department
Personal name
Funding Source
Organization
SoonChunHyang University
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 23 | 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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 11 | 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
| 2015 | Year | 03 | Month | 23 | Day |
Last modified on
| 2016 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019187
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| Registered date | File name |
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| Registered date | File name |
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