UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003062 |
|---|---|
| Receipt number | 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 23:28:02 |
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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
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
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003717
