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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040454
Receipt No. R000046174
Scientific Title Endoscopic retrograde cholangiopancreatography (ERCP) using a short-type single-balloon enteroscope in patients with surgically altered gastrointestinal anatomy: A multicenter Retrospective study
Date of disclosure of the study information 2020/06/01
Last modified on 2021/05/21

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Basic information
Public title Endoscopic retrograde cholangiopancreatography (ERCP) using a short-type single-balloon enteroscope in patients with surgically altered gastrointestinal anatomy: A multicenter Retrospective study
Acronym Short-SBE assisted ERCP: A multicenter Retrospective study
Scientific Title Endoscopic retrograde cholangiopancreatography (ERCP) using a short-type single-balloon enteroscope in patients with surgically altered gastrointestinal anatomy: A multicenter Retrospective study
Scientific Title:Acronym Short-SBE assisted ERCP: A multicenter Retrospective study
Region
Japan

Condition
Condition choledocholithiasis, Obstructive jaundice, malignant biliary obstruction, pancreatic duct stricture
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of short-SBE assisted ERCP
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes enteroscopy success rate, biliary cannulation success rate, procedural success rate
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with surgically altered
anatomy who underwent ERCP-related
procedures between September 2011 and
August 2019.
Key exclusion criteria When Patient hopes to Cancel the study,

When researcher judges that it is not appropriate case
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Tanisaka
Organization Saitama Medical University International Medical Center
Division name Gastroenterology
Zip code 350-1298
Address Yamane, Hidaka, Saitama 1397-1
TEL 042-984-4111
Email tanisaka1205@gmail.com

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Tanisaka
Organization Saitama Medical University International Medical Center
Division name Gastroenterology
Zip code 350-1298
Address Yamane, Hidaka, Saitama 1397-1
TEL 042-984-4111
Homepage URL
Email tanisaka1205@gmail.com

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University International Medical Center
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 Saitama Medical University International Medical Center IRB center
Address Yamane, Hidaka, Saitama 1397-1
Tel 042-984-4111
Email chikens@saitama-med.ac.jp

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
2020 Year 06 Month 01 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 1318
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
2019 Year 09 Month 04 Day
Date of IRB
2019 Year 09 Month 04 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Cases will be accumulated after passing through IRB at each institution.

Management information
Registered date
2020 Year 05 Month 20 Day
Last modified on
2021 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046174

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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