UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005755 |
|---|---|
| Receipt number | R000006670 |
| Scientific Title | Clinical impact of carbon dioxide insufflation during ERCP; A phase 3, open-label, randomized controled trial. |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2012/09/28 12:42:39 |
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Basic information
Public title
Clinical impact of carbon dioxide insufflation during ERCP; A phase 3, open-label, randomized controled trial.
Acronym
Carbon dioxide insufflation during ERCP
Scientific Title
Clinical impact of carbon dioxide insufflation during ERCP; A phase 3, open-label, randomized controled trial.
Scientific Title:Acronym
Carbon dioxide insufflation during ERCP
Region
| Japan |
Condition
Condition
pancreato-biliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of carbon dioxide insufflation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Visual analogue scale (VAS)
Key secondary outcomes
change of waist size
duration of sedative effect
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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
pancreato-biliary disease,
ERCP required
Key exclusion criteria
inability to provide informed consent
chronic obstructive pulmonary disease
severe abdominal pain before ERCP
pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TESSHIN BAN |
Organization
Nagoya daini red cross hospital
Division name
gastroenterology
Zip code
Address
2-9 Myokencho, showa-ku, Nagoya, Japan
TEL
052-832-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TESSHIN BAN |
Organization
Nagoya daini red cross hospital
Division name
gastroenterology
Zip code
Address
2-9 Myokencho, showa-ku, Nagoya, Japan
TEL
052-832-1121
Homepage URL
Sponsor or person
Institute
department of gastroenterology, Nagoya daini red cross hospital
Institute
Department
Personal name
Funding Source
Organization
department of gastroenterology, Nagoya daini red cross hospital
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
| 2011 | Year | 07 | 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
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
| 2011 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 10 | Day |
Last modified on
| 2012 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006670
