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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030031
Receipt No. R000034292
Scientific Title Safety of endoscopic sphincterotomy in patients undergoing antithrombotic treatment
Date of disclosure of the study information 2017/11/19
Last modified on 2017/11/18

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Basic information
Public title Safety of endoscopic sphincterotomy in patients undergoing antithrombotic treatment
Acronym Endoscopic sphincterotomy undergoing antithrombotic treatment
Scientific Title Safety of endoscopic sphincterotomy in patients undergoing antithrombotic treatment
Scientific Title:Acronym Endoscopic sphincterotomy undergoing antithrombotic treatment
Region
Japan

Condition
Condition Pancreas and biliary tract disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety of endoscopic sphincterotomy in patients undergoing antithrombotic treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of adverse events
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 undergoing antithrombotic treatment
Patients who underwent endoscopic sphincterotomy
Patients with naive papilla
Key exclusion criteria Patients with altered gastrointestinal anatomy
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Kitamura
Organization Showa University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8535
Email k.kitamura@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Kitamura
Organization Showa University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8535
Homepage URL
Email k.kitamura@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization None
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
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
2017 Year 11 Month 19 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
2017 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study
Case control study
(Patients who discontinued antithrombotic treatmentl vs. patients who continued antithrombotic treatment)
From January 2014 to December 2016

Management information
Registered date
2017 Year 11 Month 18 Day
Last modified on
2017 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034292

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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