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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000021253
Receipt No. R000024519
Scientific Title A role for wire-guided intraduodenal ultrasonography using a catheter probe in the differential diagnosis of enlarged ampullary lesions
Date of disclosure of the study information 2016/12/31
Last modified on 2016/12/27

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Basic information
Public title A role for wire-guided intraduodenal ultrasonography using a catheter probe in the differential diagnosis of enlarged ampullary lesions
Acronym A role for wire-guided IDUS using a catheter probe in the differential diagnosis of enlarged ampullary lesions
Scientific Title A role for wire-guided intraduodenal ultrasonography using a catheter probe in the differential diagnosis of enlarged ampullary lesions
Scientific Title:Acronym A role for wire-guided IDUS using a catheter probe in the differential diagnosis of enlarged ampullary lesions
Region
Asia(except Japan)

Condition
Condition enlarged ampullary lesions
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study evaluated the accuracy of wire-guided intraduodenal US using a catheter US probe during ERCP, for the differential diagnosis of an enlarged AOV.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation for the accuracy of wire-guided intraduodenal US using a catheter US probe during ERCP, for the differential diagnosis of an enlarged AOV
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 wire-guided intraduodenal US using a catheter probe
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
18 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria the presence of an enlarged AOV without definite cause as revealed by cross-sectional images (computed tomography [CT] or magnetic resonance imaging [MRI]) or endoscopic images during ERCP for the evaluation of patients with clinical symptoms of biliary obstruction (jaundice, abdominal pain, and fever); age >18 years; and the ability to provide informed consent.
Key exclusion criteria Patients with a diagnosed cause of enlarged AOV revealed by cross-sectional images or endoscopic visualization and who had undergone any prior AOV procedure including sphincterotomy or biopsy
Target sample size 36

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
Email jhmoon@schmc.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Yun Nah Lee
Organization Department of Internal Medicine, Soon Chun Hyang 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
Email yunnah@schmc.ac.kr

Sponsor
Institute SoonChunHyang University School of Medicine
Institute
Department

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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 MD_SCHBC_IRB_2013-07
Org. issuing International ID_1 MD_SCHBC_IRB_2013-07
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 31 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 Suspended
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 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
2016 Year 02 Month 29 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024519

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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