UMIN-CTR Clinical Trial

Public title

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Acronym

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Scientific Title

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Scientific Title:Acronym

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Region

Japan

Condition

Middle-lower bile duct obstruction caused by malignant tumors such as pancreas cancer,papilla Vater cancer,bile duct cancer,gallbladder cancer,malignant lymphoma,lymph node metastasis,etc

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Investigate of the usefulness of metallic stents with long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Duration until stent dysfunction

Key secondary outcomes

Overall survival, Kinds and frequency of the complication, A effective rate of the stent in the time of death

Study type

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We will place metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors into the obstructive portion and research duration until stent dysfunction,overall survival,the kinds and frequency of the complication,the effective rate of the stent in the time of death.
Reseach period; Up to the day passed 12 months from the day started to follow the last registrant(30th case).

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Cases of biliary obstruction caused by middle-lower bile duct malignant tumors
2.As a general rule, cases in which a pathological definitive diagnosis was obtained (regardless of whether they were cases of cytodiagnosis or histological diagnosis). In addition, even if, for some reason or other, a pathological definitive diagnosis was not obtained, cases in which a clear diagnosis was obtained through such means as clinical findings, tumor markers, US, CT, MRI, etc. were also used as subjects for investigation.
3.Cases for which no plans have been made for carrying out radical resection.
4.Concerning participation in the study, patients who provide informed consent (as a general rule, the patients must be carried out of cancer notification).

Key exclusion criteria

1.Cases in which informed consent cannot be obtained
2. Cases in which there was poor first biliary tract drainage
3.Others, including cases in which the principal investigator (or sub-investigator) in the study judges the patient to be unsuitable as a subject for the investigation such as cases of severe dysfunction of the cardiopulmonary performance, dementia, etc.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuo Tokuhara

Organization

Daito-central hospital

Division name

internal medicine department

Zip code

Address

2-1-11 Ono,Daito-shi,Osaka,Japan

TEL

072-870-0200

Email

tokuman.am@wing.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Mitsuo Tokuhara

Organization

Daito-central hospital

Division name

internal medicine department

Zip code

Address

2-1-11 Ono,Daito-shi,Osaka,Japan

TEL

072-870-0200

Homepage URL

Email

tokuman.am@wing.ocn.ne.jp

Institute

Daito-central hospital

Institute

Department

Personal name

Organization

Daito-central hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

01

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2015

Year

01

Month

23

Day

Date of IRB

Anticipated trial start date

2015

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

01

Month

18

Day

Last modified on

2015

Year

01

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015527