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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021440
Receipt No. R000024538
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.
Date of disclosure of the study information 2016/03/12
Last modified on 2020/03/22

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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/ctr_e/ctr_view.cgi?recptno=R000024538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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