UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024489 |
|---|---|
| Receipt number | R000028183 |
| Scientific Title | Long-term outcomes after the therapeutic ERCP using the balloon-assisted endoscopy for anastomotic stenosis of choledocho-jejunostomy or pancreatico-enterostomy |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2016/10/19 20:31:19 |
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Basic information
Public title
Long-term outcomes after the therapeutic ERCP using the balloon-assisted endoscopy for anastomotic stenosis of choledocho-jejunostomy or pancreatico-enterostomy
Acronym
Long-term outcomes after the therapeutic ERCP using the balloon-assisted endoscopy for anastomotic stenosis of choledocho-jejunostomy or pancreatico-enterostomy
Scientific Title
Long-term outcomes after the therapeutic ERCP using the balloon-assisted endoscopy for anastomotic stenosis of choledocho-jejunostomy or pancreatico-enterostomy
Scientific Title:Acronym
Long-term outcomes after the therapeutic ERCP using the balloon-assisted endoscopy for anastomotic stenosis of choledocho-jejunostomy or pancreatico-enterostomy
Region
| Japan |
Condition
Condition
anastomotic stenosis of choledochojejunostomy or pancreaticojejunostomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the long-term outcomes after the therapeutic ERCP using theballoon-assisted endoscopy for anastomotic stenosis of choledochojejunostomy or pancreaticojejunostomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Choledocojejunostomy and pancreaticojejunostomy recurrence rates after the initial treatment using balloon-assisted endoscopy for anastmotic stenosis
Key secondary outcomes
Initial therapy details for choledocojejunostomy or pancreaticojejunostomy, initial therapy complications, treatment details for choledocojejunostomy or pancreaticojejunostomy recurrence
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
| 200 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who achieved technical and clinical success for choledochojejunostomy or pancreaticojejunostomy by BAE-ERCP, and could be followed up for more than 6 months after the initial treatment, patients over 20 years of age
Key exclusion criteria
Patients with malignant anastomotic stenosis or those who underwent therapeutic procedures except BAE, such as the EUS-guided or percutaneous approach, in the initial treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Katanuma |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
Address
1-12 Maeda, Teine-ku, Sapporo 006-8555, Japan
TEL
011-681-8111
akatanuma@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itsuki Sano |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
Address
1-12 Maeda, Teine-ku, Sapporo 006-8555, Japan
TEL
011-681-8111
Homepage URL
itsukisano@hotmail.co.jp
Sponsor or person
Institute
Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
手稲渓仁会病院(北海道)，北海道大学病院(北海道)，札幌医科大学病院(北海道)，福島医科大学会津医療センター(福島県)，埼玉医科大学国際医療センター(埼玉県)，東京医科大学病院(東京都)，山口大学病院(山口県)，帝京大学附属溝の口病院(東京都)，久留米大学病院(福岡県)，岡山大学病院(岡山県)，岐阜大学病院(岐阜県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Performing a retrospective observational study based on the endoscopy datebases at 11 Japanese institutions in patients who underwent BAE-ERCP for CJS or PJS between September 2009 and December 2015.
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2016 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028183
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
