UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter prospective study to assess utility and safety of a metal stent with low axial force for obstructive jaundice in patients with unresectable malingant distal biliary stenosis.
Acronym	A multicenter prospective study to assess utility and safety of a metal stent
Scientific Title	A multicenter prospective study to assess utility and safety of a metal stent with low axial force for obstructive jaundice in patients with unresectable malingant distal biliary stenosis.
Scientific Title:Acronym	A multicenter prospective study to assess utility and safety of a metal stent
Region	Japan

Condition
Condition	Obstructive jaundice
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the clinical outcome of a new self-expandable metal stent with low axial force for drainage treatment of obstructive jaundice due to unresectable malignant distal biliary stenosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	stent patency
Key secondary outcomes

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. patinets with unresectable malignant distal biliary stenosis with histological evidence 2. ECOG(Eastern Cooperative Oncology Group) performance status 0-3 3. Written informed consent
Key exclusion criteria	1. Inability to expect efficacy of biliary drainage 2. severe failure of the other organs: ASA classification of 3 or more 3. ECOG performance status 4 4. poor prognosis of 3 months or less 5. complication with hilar stenosis due to lymph node metastasis 6. post-surgical reconstruction of bile duct
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Yamao
Organization	Kinki University faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	589-8511
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Email	yamaken_volvo@yahoo.co.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Yamao
Organization	Kinki University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	589-8511
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Homepage URL
Email	yamaken_volvo@yahoo.co.jp

Sponsor
Institute	Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	Kinki University Faculty of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institute Review Board in Kidai University
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, Japan
Tel	072-366-0221
Email	zizen@med.kindai.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	大阪医科大学病院(大阪)、ベルランド総合病院(大阪)、日本赤十字社医療センター(和歌山県)、豊中市立病院(大阪)、北野病院(大阪)、宝塚市立病院(兵庫県)、神戸大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 12 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	2016 Year 02 Month 01 Day
Date of IRB	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 15 Day
Last follow-up date	2018 Year 05 Month 30 Day
Date of closure to data entry	2018 Year 06 Month 30 Day
Date trial data considered complete	2018 Year 07 Month 30 Day
Date analysis concluded	2019 Year 04 Month 01 Day

Other
Other related information	Study design: Cohort study Patients: All consective patients with inclusion criteria in February, 2016-December, 2017. To assess utility and safety of a new self-expandable metal stent with low axial force for drainage treatment of obstructive jaundice due to unresectable malignant distal biliary stenosis.

Management information
Registered date	2016 Year 03 Month 11 Day
Last modified on	2020 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024538