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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003062
Receipt No. R000003717
Scientific Title A randomized, double-blind, controlled multicenter trial for availability of carbon dioxide insufflation during ERCP for reduction of postprocedure pain
Date of disclosure of the study information 2010/01/20
Last modified on 2011/06/02

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Basic information
Public title A randomized, double-blind, controlled multicenter trial for availability of carbon dioxide insufflation during ERCP for reduction of postprocedure pain
Acronym Availability of carbon dioxide insufflation during ERCP for reduction of postprocedure pain
Scientific Title A randomized, double-blind, controlled multicenter trial for availability of carbon dioxide insufflation during ERCP for reduction of postprocedure pain
Scientific Title:Acronym Availability of carbon dioxide insufflation during ERCP for reduction of postprocedure pain
Region
Japan

Condition
Condition pancreaticobiliary disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether carbon dioxide insufflation is more available than air insufflation during ERCP for reduction of postprocedure pain and discomfort.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gas volume in the bowel 5 minutes after ERCP and 10-point visual analogue scale(VAS) score of abdominal panin or discomfort 3 and 24 hours after ERCP
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 CO2 insufflation
Interventions/Control_2 Air insufflation
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases necessary for ERCP for diagnosis or treatment
Key exclusion criteria Cases who are <20 years old
Cases for whom enforcement of ERCP is inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Kuwatani
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address North 15, West 7, Kita-ku, Sapporo 060-8638, Japan
TEL 011-716-1161
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email mkuwatan@med.hokudai.ac.jp

Sponsor
Institute Department of Gastroenterology, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology, Hokkaido University Graduate School of Medicine
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
2010 Year 01 Month 20 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
2009 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 05 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 19 Day
Last modified on
2011 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003717

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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