UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021018 |
|---|---|
| Receipt number | R000024256 |
| Scientific Title | Efficacy of short-type single-balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy: Factors affecting technical difficulty |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2017/02/17 18:46:52 |
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Basic information
Public title
Efficacy of short-type single-balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy: Factors affecting technical difficulty
Acronym
Efficacy and factors affecting technical difficulty of short-SBE assisted ERCP
Scientific Title
Efficacy of short-type single-balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy: Factors affecting technical difficulty
Scientific Title:Acronym
Efficacy and factors affecting technical difficulty of short-SBE assisted ERCP
Region
| Japan |
Condition
Condition
Pancreatobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the procedural success rate of short-SBE assisted ERCP and factors affecting technical difficulty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedural success rate of short SBE assisted ERCP.
Key secondary outcomes
Factors that affect enteroscopy and procedural failure.
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 altered upper GI anatomy who underwent short-SBE assisted ERCP
Key exclusion criteria
1, Patients whom the principal investigator considered to be inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yane |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
Address
1-jo, 12-chome, Maeda, Teine-ku, Sapporo
TEL
011-681-8111
k.yane3@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Yane |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
Address
1-jo, 12-chome, Maeda, Teine-ku, Sapporo
TEL
011-681-8111
Homepage URL
k.yane3@gmail.com
Sponsor or person
Institute
Center for Gastroenterology, Teine-Keijinkai Hospital
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
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
| 2016 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0042-118301
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
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 23 | Day |
Other
Other related information
Observational study
Patients:
All patients with surgically altered anatomy who underwent ERCP using prototype short SBEs in Teine keijinkai hospital between June 2011 and November 2015.
Methods:
We retrospectively examined the procedural success rate of ERCP and the risk factors that could affect procedural failure.
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2017 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024256
