UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term outcomes after the therapeutic ERCP using the balloon-assisted endoscopy for anastomotic stenosis of choledocho-jejunostomy or pancreatico-enterostomy
Title of the study (Brief title)	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	Akio Katanuma
Organization	Teine-Keijinkai Hospital
Division name	Center for Gastroenterology
Address	1-12 Maeda, Teine-ku, Sapporo 006-8555, Japan
TEL	011-681-8111
Email	akatanuma@gmail.com

Public contact
Name of contact person	Itsuki Sano
Organization	Teine-Keijinkai Hospital
Division name	Center for Gastroenterology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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