UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Acronym	Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Scientific Title	Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Scientific Title:Acronym	Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Region	Japan

Condition
Condition	unresectable distal biliary obstruction
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of metallic stent of uncovered metallic stent and covered metallic stent for distal biliary tract obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	stent patency obstruction rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Uncovered metallic stent
Interventions/Control_2	Covered metallic stent
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. Having lower part biliary tract stenosis in the unresectable malignancy; an adaptation patient of endoscopic retrograde bile duct pancreatic duct contrasting (ERCP). 2. It can be indicated the art of endoscopic duodenal nipple incision and drainage, and an agreement is provided when it enforces it again. 3. When I perform a pathological search and get a malignant definitive diagnosis, or a malignancy is diagnosed by an image and hematologic inspection clinically even if I perform a pathological search when a malignant diagnosis is difficult. 4.Performance status is a patient of 0-2. 5.Having chemoradiation treatment combination or not does not matter. 6.Age is a patient 20 years or older at the agreement acquisition. 7.A document agreement by the free will of the patient person is provided in the one which understands enough it after having received enough explanation on participating of the final examination case 8 within 30th from the first drainage. 9.I am limited to a patient admitted to other Houses after hospitalization or treatment.
Key exclusion criteria	1.The patient who has bile duct stenosis in the liver from a hepatic portal region. 2.A state is extremely bad from head to foot. 3.) not to include the case that removed duodenal confinement by patient (Stent or the operation that duodenal 3rd portion blocked up. 4. The patient who cannot agree to endoscopic retrograde bile duct pancreatic duct contrasting (ERCP) or endoscopic treatment (endoscopic nipple incision, art of drainage). 5.The patient with the allergy to metal. 6.A patient with a history of the custody of the past metallic stent. 7.A patient considered to be below 30 days in convalescence.
Target sample size	98

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshio Tsuyuguchi
Organization	Chiba University
Division name	Gastroenterology
Zip code
Address	Inohana 1-8-1, Chuou-ku, Chiba City, 260-8670, Japan.
TEL	81-43-2262083
Email	sakai4754@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yuji Sakai
Organization	Chiba Univeresity
Division name	Gastroenterology
Zip code
Address	Inohana 1-8-1, Chuou-ku, Chiba City, 260-8670, Japan.
TEL	81-43-2262083
Homepage URL
Email	sakai4754@yahoo.co.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Boston Scientific Japan
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 10 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	2014 Year 01 Month 01 Day
Date of IRB	2013 Year 12 Month 16 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 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 09 Month 09 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=R000017551