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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024489
Receipt No. 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

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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
Email 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
Email itsukisano@hotmail.co.jp

Sponsor
Institute Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028183

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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