UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006779
Receipt No. R000008023
Scientific Title Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction. A prospective phase II trial.
Date of disclosure of the study information 2011/12/01
Last modified on 2019/03/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Plastic stent placement above the
sphincter of Oddi ("inside-stent") for
patients of malignant hilar biliary obstruction. A prospective phase II trial.
Acronym Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction.
Scientific Title Plastic stent placement above the
sphincter of Oddi ("inside-stent") for
patients of malignant hilar biliary obstruction. A prospective phase II trial.
Scientific Title:Acronym Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction.
Region
Japan

Condition
Condition Malignant hilar biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficancy and safety of plastic stent placement above the sphincter of Oddi for patients of malignant hilar biliary obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Time to dysfunction
Key secondary outcomes 1.Dysfunction rate and substance
2.Complication rate and substance
3.Suvival time
4.Re-intervention rate and method
5.Operation time
6.success rate of operation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A plastic stent which is attached a nylon string is used. The plastic stent is placed endoscopically above the sphincter of Oddi for malignant hilar biliary obstruction.
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.Unresectable malignant hilar biliary obstruction is proven by pathological or radiological diagnosis.
2.A stent placement is needed.
3.The therapy of a stent placement have never been performed.
4.Endoscopic stenting can be performed.
5.A stent can be placed above the sphincter of Oddi.
6.Written informed concent of the print.
Key exclusion criteria 1.The prognosis is considered within 3 months.
2.They have jaundice which can't be improved by stenting. For example, liver failure.
3.Decision of unsuitableness by principal investigator.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Sugimori
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email ycu.umin@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Ishii
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email tishii@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Gastroenterological Center
Institute
Department

Funding Source
Organization None
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
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 横浜市立大学附属市民総合医療センター(神奈川県)
神奈川県立がんセンター(神奈川県)
昭和大学藤が丘病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 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 Terminated
Date of protocol fixation
2011 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 28 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.