UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for recurrent obstruction of covered metal stent for distal malignant biliary obstruction
Title of the study (Brief title)	ARMS as a reintervention
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 recurrent occlusion of conventional covered metal stent as a result of sludge or food impaction.
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Institution is considered as adjustment factor in dynamic allocation.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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. Covered metal stent was occluded due to the duodenobiliary reflux within 90 days of stent placement, and cholantitis subsided via endoscopic biliary drainage 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	66

Research contact person
Name of lead principal investigator	Hiroyuki Isayama
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology,
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	Hiroyuki Isayama
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology,
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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 07 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 26 Day
Anticipated trial start date	2014 Year 08 Month 06 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

Management information
Registered date	2014 Year 07 Month 17 Day
Last modified on	2016 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016957