UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013949 |
|---|---|
| Receipt number | R000015625 |
| Scientific Title | Efficacy and safety of diagnostic and therapeutic ERCP using a short double-balloon enteroscope |
| Date of disclosure of the study information | 2014/05/13 |
| Last modified on | 2016/12/08 00:08:50 |
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Basic information
Public title
Efficacy and safety of diagnostic and therapeutic ERCP using a short double-balloon enteroscope
Acronym
Efficacy and safety of ERCP using a short double-balloon enteroscope
Scientific Title
Efficacy and safety of diagnostic and therapeutic ERCP using a short double-balloon enteroscope
Scientific Title:Acronym
Efficacy and safety of ERCP using a short double-balloon enteroscope
Region
| Japan |
Condition
Condition
pancreatobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of diagnostic and therapeutic ERCP using a short double-balloon enteroscope.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate of the diagnostic and therapeutic ERCP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Double-balloon enteroscope
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, Postoperative surgical patients with pancreatobiliary disease.
2, Patients of age =>20.
3, Written informed consent is required from all patients.
Key exclusion criteria
1, Patients with serious complication in other organ.
2, Patients with severe general condition.
3, Patients who don't give informed consent.
4, Inappropriate patients for entry on this study in the judgement of the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan, 700-8558
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Tsutsumi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan, 700-8558
TEL
086-235-7219
Homepage URL
tsutsumi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University 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
| 2014 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/25041448
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
| 2012 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015625
