UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009778
Receipt No. R000002157
Scientific Title A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.
Date of disclosure of the study information 2013/01/14
Last modified on 2014/02/19

* 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 A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.
Acronym "Covered" vs "uncovered" metallic stents for biliary stricture by unresectable pancreatic cancer.
Scientific Title A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.
Scientific Title:Acronym "Covered" vs "uncovered" metallic stents for biliary stricture by unresectable pancreatic cancer.
Region
Japan

Condition
Condition Biliary stricture caused by unresectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of covered metallic stent (CMS) and uncovered metallic stent (UMS)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes duration until stent dysfunction
Key secondary outcomes 1) overall survival
2) incidence of side effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Covered metallic stent (CMS)
Interventions/Control_2 Uncovered metallic stent (UMS)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pancreatic head cancer with biliary stricture
2) Pathological confirmation is essential.
3) Stricture of bile duct is middle to lower common bile duct.
4) Clinical stage (UICC) is more than stage 2b.
5)Informed consent is essential.
Key exclusion criteria 1) PS > 4.
2) Severe complication of another organ.
3) A patient who gives no written IC.
4) A participating doctor thinks the patient is not proper for this study.
5) Prognosis will be within 3 months.
6) Initial drainage worsen the status of the patient.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Mukai
Organization Yodogawa Christian Hospital
Division name Department of Gastroenterology
Zip code
Address Awaji 2-9-26, Higashiyodogawa-Ku, Osaka
TEL 06-6322-2250
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyohito Tanaka
Organization Kyoto Second Red Cross Hospital
Division name Department of Gastoroenterology
Zip code
Address
TEL 075-231-5171
Homepage URL
Email

Sponsor
Institute Kansai Endoscopic Device Selection (EDS) Working Group
Institute
Department

Funding Source
Organization Kansai Endoscopic Device Selection (EDS) Working Group
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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/ajg/journal/v108/n11/full/ajg2013305a.html
Number of participants that the trial has enrolled
Results
Patient survival time in the two groups did not signifi cantly differ (median: 285 and 223 days,
respectively; P = 0.68). Patient survival time without stent dysfunction was signifi cantly longer
in the covered than in the uncovered SEMS group (median: 187 vs. 132 days; P = 0.043).Stent patency was also signifi cantly longer in the covered than in the uncovered SEMS group
(mean +- s.d.: 219.3 +- 159.1 vs. 166.9 +- 124.9 days; P = 0.047).Rates of tumor overgrowth and sludge formation did not signifi
cantly differ between the two groups, whereas the rate of tumor ingrowth was signifi cantly lower
in the covered than in the uncovered SEMS group ( P < 0.01).There was no signifi cant difference between
the two groups in the incidence of serious adverse events.
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
2009 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 24 Day
Date trial data considered complete
2012 Year 02 Month 25 Day
Date analysis concluded
2012 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 14 Day
Last modified on
2014 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002157

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.