UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction
Acronym	ARMS as the initial SEMS
Scientific Title	A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction
Scientific Title:Acronym	ARMS as the initial SEMS
Region	Japan

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

Objectives
Narrative objectives1	To compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to recurrent biliary obstrution after the placement of metal stent
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Endoscopic placement of antireflux metal stent for biliay obstruction
Interventions/Control_2	Endoscopic placement of conventional covered metal stent for biliay obstruction
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. nonresectable malignant biliary obstruction 2. distal biliary obstruction (2 cm or longer from the bifurcation) 3. Without a history of biliary SEMS placement 4. Irrespective of sex and a primary disease 5. Written informed consent obtained
Key exclusion criteria	1. Endoscopic approach to the biliary system is impossible 2. Hilar biliary obstruction 3. Performance status is four 4. Gastrointestinal obstruction distal to the papilla (patients whose gastrointestinal obstruction was resolved via a stent or surgical bypass can be included) 5. Severe comobidities in other organs 6. Pregnant women or those suspected of pregnancy 7. Written informed consent not obtained 8. Patients considered ineligible by attending physicians
Target sample size	104

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Isayama
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology,
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	+81-3-3815-5411
Email	isayama-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Isayama
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology,
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	+81-3-3815-5411
Homepage URL
Email	isayama-tky@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	Century Medical, Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2014 Year 08 Month 15 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	2014 Year 08 Month 04 Day
Date of IRB	2014 Year 08 Month 06 Day
Anticipated trial start date	2014 Year 08 Month 20 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 06 Day
Last modified on	2021 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017189