UMIN-CTR Clinical Trial

Basic information
Public title	The feasibility of the new designed biliary metallic stent with distal tapering shape for the unresectable distal biliary malignancies: A pilot study
Acronym	BULLET trial
Scientific Title	The feasibility of the new designed biliary metallic stent with distal tapering shape for the unresectable distal biliary malignancies: A pilot study
Scientific Title:Acronym	BULLET trial
Region	Japan

Condition
Condition	Unresectable distal malignant biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the patency and safety of newly developed tapered Niti-S stent for distal malignancy biliary obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Stent malfunction and obstruction rate Stent patency period
Key secondary outcomes	Median survival period The incidence of adverse event

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) Unresectable distal biliary malignant obstruction (regardless of primary disease) 2) Never received treatment with SEMS 3) Cases with expected prognosis of more than 2 months 4) 20 years or older 5) Cases with informed consent after sufficient explanation from physician and patient's understanding 6) 2 or less in ECOG performance status
Key exclusion criteria	1) Massive ascites 2) Cases with serious complications in other organs 3) Hilar biliary obstruction 4) Altered anatomy following Billroth-II or Roux-en-Y gastrectomy 5) Case in which ERCP is difficult to perform 6) Duodenal stenosis on the anal side more than the duodenal papilla (cases improved with the duodenal stent can be enrolled) 7) Case in which the physician judged inappropriate for some reason
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shinpei Middle name Last name Shinpei
Organization	Teikyo University School of medicine University Mizonokuchi Hospital
Division name	Dept of Gastroenterology
Zip code	213-8507
Address	5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa
TEL	044-844-3333
Email	sinpesan@gmail.com

Public contact
Name of contact person	1st name Shinpei Middle name Last name Shinpei
Organization	Teikyo University School of medicine University Mizonokuchi Hospital
Division name	Dept of Gastroenterology
Zip code	213-8507
Address	5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa
TEL	044-844-3333
Homepage URL
Email	sinpesan@gmail.com

Sponsor
Institute	Dept of Gastroenterology, Teikyo University School of medicine University Mizonokuchi Hospital
Institute
Department

Funding Source
Organization	Dept of Gastroenterology, Teikyo University School of medicine University Mizonokuchi Hospital
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	Teikyo University Ethics Committee Secretariat
Address	2-11-1, Kaga, Itabashi-ku, Tokyo
Tel	03-3964-7256
Email	turb-office@teikyo-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	帝京大学医学部附属溝口病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 11 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	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 01 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 10 Month 11 Day
Last modified on	2020 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034711