UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032680 |
|---|---|
| Receipt number | R000037266 |
| Scientific Title | prospective interventional study compare between Carbon dioxide insufflation method and conventional visual confirmation method for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with surgically altered GI anatomy |
| Date of disclosure of the study information | 2018/05/25 |
| Last modified on | 2020/05/23 14:34:33 |
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Basic information
Public title
prospective interventional study compare between Carbon dioxide insufflation method and conventional visual confirmation method for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with surgically altered GI anatomy
Acronym
prospective interventional study compare between Carbon dioxide insufflation method and conventional visual confirmation method for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with surgically altered GI anatomy
Scientific Title
prospective interventional study compare between Carbon dioxide insufflation method and conventional visual confirmation method for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with surgically altered GI anatomy
Scientific Title:Acronym
prospective interventional study compare between Carbon dioxide insufflation method and conventional visual confirmation method for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with surgically altered GI anatomy
Region
| Japan |
Condition
Condition
Biliary pancreatic diseases with surgically altered GI anatomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we like to show the superiority of CO2 method to the visual observation method at the point of reaching time to the final target, the post-operative anastomosis or Vater papilla, after starting the examination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Initial selection rate to afferent loop
Key secondary outcomes
reaching time to the final target, the post-opetrative anastomosis or Vater papilla, after starting the examination.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
carbon dioxide insufflation method
Interventions/Control_2
conventional visual confirmation method
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
informed concent
biliary pancreatic diseases with surgically altered GI anatomy
Key exclusion criteria
Patients with acute abdomen
Patients with severe acute inflammation
pregnant patient
general condition is very poor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masanao |
| Middle name | |
| Last name | Nakamura |
Organization
Nagoya University Graduate School of medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumaichou,shouwa-ku,Nagoya,Aichi 466-8550
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Murate |
| Middle name | |
| Last name | Kentaro |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumaichou,shouwa-ku,Nagoya,Aichi 466-8550
TEL
052-741-2172
Homepage URL
km1219@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
ethical committe of Nagoya University Graduate School of medicine
Address
65 Tsurumaichou,shouwa-ku,Nagoya,Aichi 466-8550
Tel
052-744-2973
ethics@med.nagoya-u.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
| 2018 | Year | 05 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 22 | Day |
Last modified on
| 2020 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037266
