UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study
Acronym	Efficacy of inside metallic stent for benign biliary stricture
Scientific Title	Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study
Scientific Title:Acronym	Efficacy of inside metallic stent for benign biliary stricture
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stent placement.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of stricture resolution at metallic stent removal after 4 month stent placement
Key secondary outcomes	1.Success rate of stent placement 2.Success rate of stent removal 3. Rate of stricture recurrence 4. Adverse events

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with refractory benign biliary strictures (Resolution of stricture was not achieved by plastic stent treatment). 2.Malignancy is ruled out by pathological examination and clinical course. 3.Biliary stricture was completely existed on ERC findings, or no flow of contrast material into the downstream within 60 seconds, if stenosis was incomplete. 4.Biliary strictures located above the ampulla 15 mm or more upstream.(Metallic stent could be placed inside the bile duct )
Key exclusion criteria	1.Patients with performance status 3 or 4 2.Patients with severe complications to other organs. 3.Stricture of intrahepatic bile duct 4.Age<20 5.Patients without informed concent 6.The size of bile duct size showed less than 8 mm on first ERC finding. 7.Patients with severe coagulation dysfunction. 8.Patients with hepaticojejunostomy 9.Patients judged inappropriate by chief medical examiner.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hironari Middle name Last name Kato
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code	7008558
Address	2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL	086-235-7219
Email	drkatocha@yahoo.co.jp

Public contact
Name of contact person	1st name Kazuyuki Middle name Last name Matsumoto
Organization	Okayama University Hospital
Division name	Department of Endoscopy
Zip code	7008558
Address	2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL	086-235-7219
Homepage URL
Email	matsumotokazuyuki0227@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital Department of Gastroenterology
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1,shikata-cho, okayama city, okayama
Tel	086-235-7219
Email	mae6605@adm.okayama-u.ac.jp

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	2017 Year 06 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	22
Results	The technical success rate of intraductal FCSEMS placement was 100% The rate of successful stent removal at four months was 100% and stricture resolution was observed in 91% of patients. Bile leak due to guidewire injury occurred in one patient, but stent migration or stent-induced de novo stricture did not occur in any patient. The stricture recurrence rate was 16%, and the median(interquartile range)follow-up duration was 2.8(1.6-3.3)years. 1-year and 2-year recurrence free rate were 89% and 84%
Results date posted	2022 Year 01 Month 31 Day
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	2017 Year 05 Month 23 Day
Date of IRB	2017 Year 05 Month 12 Day
Anticipated trial start date	2017 Year 05 Month 23 Day
Last follow-up date	2021 Year 07 Month 30 Day
Date of closure to data entry	2021 Year 08 Month 30 Day
Date trial data considered complete	2021 Year 09 Month 30 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information	Observation period: 12 month(after metallic stent removal)

Management information
Registered date	2017 Year 06 Month 01 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031198