UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Acronym	The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Scientific Title	The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Scientific Title:Acronym	The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Region	Japan

Condition
Condition	bilioenteric anastomotic stricture
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to evaluate the efficacy and safety of balloon dilation and stent deployment for the biliary anastomotic stricture by double balloon enteroscope
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1-year biliary anastomotic stricture recurrence free rates
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
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who suspected to the bilioenteric anastomotic stricture
Key exclusion criteria	1)Patients with performance status 4 2)Age<20 3)Patients with a history of balloon dilation for the biliary anastomotic stricture 4)Patients with the biliary anastomotic stricture due to malignant disease 5)Patients after living-donor liver transplantation and deceased donor liver transplantaion 6)Patients without informed concent 7)patients who are judged inappropriate by chief medical examiner
Target sample size	40

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 Hepatology
Zip code
Address	2-4-1 Shikata-cho Kita-ku Okayama-city Okayama
TEL	086-235-7219
Email	drkatocha@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Tomoda
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-4-1 Shikata-cho Kita-ku Okayama-city Okayama
TEL	086-235-7219
Homepage URL
Email	tomotake79@yahoo.co.jp

Sponsor
Institute	Okayama University 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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 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	Completed
Date of protocol fixation	2016 Year 03 Month 15 Day
Date of IRB	2016 Year 03 Month 23 Day
Anticipated trial start date	2016 Year 03 Month 23 Day
Last follow-up date	2021 Year 02 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Research design: prospective cohort study Recruiting methods of objects: all the patients who conform to the criteria visiting to Okayama University Hospital and three other hospitals affiliated to the Okayama University between March 2016 and March 2020 Measuring item: Clinical signs and liver function were followed up at three months, six months and twelve months after treatment.

Management information
Registered date	2016 Year 01 Month 18 Day
Last modified on	2020 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023797