UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014183 |
|---|---|
| Receipt number | R000016255 |
| Scientific Title | Techique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy: comparison of X-ray imagings for efficient procedure |
| Date of disclosure of the study information | 2014/06/06 |
| Last modified on | 2017/12/07 10:56:17 |
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Basic information
Public title
Techique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy: comparison of X-ray imagings for efficient procedure
Acronym
Technique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy
Scientific Title
Techique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy: comparison of X-ray imagings for efficient procedure
Scientific Title:Acronym
Technique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy
Region
| Japan |
Condition
Condition
Biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of the comparison of the X-ray imagings for selection of the correct lumen which leads the scope to the bilioenteric anastomosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of reaching the bilioenteric anastomosis accurately by the comparison of the X-ray imagings
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Patients with Roux-en Y hepaticojejunostomy and bile tract disease.
2, Written informed consent is required from patients or legal representatives
Key exclusion criteria
1, Patients who have difficulty in endoscopic approach.
2, Patients in ECOG performance status 4.
3, Patients with serious complication in other organ.
4, Patients who have side-to-side jejunojejunal anastomosis.
5, Patients who don't give informed consent.
Target sample size
32
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 Hepatolog
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, 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
Other
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
岡山大学病院（岡山県）、広島市立広島市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/DOI/DOI?10.1055/s-0043-117406
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
| 2014 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study for the assessment of the efficacy of the comparison of the X-ray imagings for selection of the correct lumen which leads the scope to the bilioenteric anastomosis in patients with Roux-en Y hepaticojejunostomy.
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2017 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016255
