UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018357 |
|---|---|
| Receipt number | R000021252 |
| Scientific Title | The usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2021/05/10 09:22:43 |
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Basic information
Public title
The usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy
Acronym
The usefulness of Carbon dioxide insufflation for DBERC in patients with altered GI anatomy
Scientific Title
The usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy
Scientific Title:Acronym
The usefulness of Carbon dioxide insufflation for DBERC in patients with altered GI anatomy
Region
| Japan |
Condition
Condition
pancreato-biliary diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the usefulness of Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with altered GI anatomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate to select the target lumen atthe branch of GI tract.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age: 20 years old or older
2) To consent to an inclusion agreement
3) Patients with altered GI anatomy who have a pancreato-biliary disease (suspected)
Key exclusion criteria
A) Acute abdomen
B) severe inflammation is complicated.
C) Pregnancy
D) Poor general condition
E) taking anti-coagulant drugs
F) having severe baseline disease for heart, lung, kidney, or liver.
G) bradycardia or A-V block on ECG
H) previously parpicipated in this study
I) Doctor's decision
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirooka Yoshiki |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nakamura Masanao |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
makamura@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
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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
| 2015 | Year | 09 | 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
| 2015 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2015 | Year | 07 | Month | 20 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021252
