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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033963
Receipt No. R000038739
Scientific Title A study on factors affecting technical difficulty of balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy
Date of disclosure of the study information 2018/08/30
Last modified on 2018/08/30

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Basic information
Public title A study on factors affecting technical difficulty of balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy
Acronym A study on factors affecting technical difficulty of balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy
Scientific Title A study on factors affecting technical difficulty of balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy
Scientific Title:Acronym A study on factors affecting technical difficulty of balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy
Region
Japan

Condition
Condition Gastroenterology
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine factors affecting technical difficulty of balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Factors that affect cannulation failure of balloon enteroscopy-assisted ERCP .
Key secondary outcomes Enteroscopy success rate, cannulation success rate, adverse events related to ERCP.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with altered upper GI anatomy and have or suspected to have biliary pancreatic disease
Key exclusion criteria Patient who did not use balloon endoscope.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name NAOYA IZAWA
Organization Dokkyo medical University
Division name Department of Gastroenterology
Zip code
Address 880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL 0282861111
Email izawanao@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name NAOYA IZAWA
Organization Dokkyo medical University
Division name Department of Gastroenterology
Zip code
Address 880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL 0282861111
Homepage URL
Email izawanao@dokkyomed.ac.jp

Sponsor
Institute Dokkyo medical University
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
2018 Year 08 Month 30 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
2018 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038739

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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