UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009779
Receipt number R000002159
Scientific Title A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer
Date of disclosure of the study information 2013/01/14
Last modified on 2014/02/19 09:18:21

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Basic information

Public title

A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer

Acronym

"Covered" vs "uncovered" metallic stents for biliary stricture by unresectable middle to lower bile duct cancer.

Scientific Title

A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer

Scientific Title:Acronym

"Covered" vs "uncovered" metallic stents for biliary stricture by unresectable middle to lower bile duct cancer.

Region

Japan


Condition

Condition

Biliary stricture caused by unresectable middle to lower bile duct cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaaluate 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) incedence 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


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) Unresectable middle to lower bile duct cancer.
2) Pathological confirmation is essential.
3) Stricuture is located to middle to lower 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 Chiristian Hospital

Division name

Department of Gastroenterology

Zip code


Address

Awaji 2-9-26 Higasiyodogawa-Ku, Osaka

TEL

06-6322-2250

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kiyohito Tanaka

Organization

Kyoto Secind Red Cross Hospital

Division name

Department of Gastroenterology

Zip code


Address


TEL

075-231-5171

Homepage URL


Email



Sponsor or person

Institute

Kansai Endoscopic Device Selection (EDS) Working Group

Institute

Department

Personal name



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

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Reintervention was performed for recurrent biliary obstruction in 18 of 72 covered SEMSs (25%) and 28 of 71 uncovered SEMSs (39%). Median stent patency times were 552 days and 314 days for the covered and uncovered SEMSs groups, respectively. The log-rank test revealed that the stent patency time in the covered SEMSs group was significantly longer than that in the uncovered SEMSs group (P=0.041). Stent dysfunction developed in 17 (23%) patients in the covered SEMSs group and in 23 (38%) patients in the uncovered SEMSs group, respectively.

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 03 Month 01 Day

Last follow-up date

2012 Year 09 Month 01 Day

Date of closure to data entry

2012 Year 10 Month 30 Day

Date trial data considered complete

2012 Year 10 Month 30 Day

Date analysis concluded

2012 Year 12 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002159


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name