UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025760
Receipt number R000029636
Scientific Title Randomized controlled trial on efficacy of metal stents vs. inside plastic stents for unresectable malignant obstruction of the perihilar bile duct
Date of disclosure of the study information 2017/02/24
Last modified on 2020/01/23 15:45:13

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Basic information

Public title

Randomized controlled trial on efficacy of metal stents vs. inside plastic stents
for unresectable malignant obstruction of the perihilar bile duct

Acronym

MiPS study

Scientific Title

Randomized controlled trial on efficacy of metal stents vs. inside plastic stents
for unresectable malignant obstruction of the perihilar bile duct

Scientific Title:Acronym

MiPS study

Region

Japan


Condition

Condition

Unresectable malignant perihilar biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of placement of inside plastic stents (PSs)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Patency period of inside PSs

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

Deployment of inside PSs

Interventions/Control_2

Deployment of metal stents (MSs)

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

a. those who have been diagnosed as malignant perihilar biliary obstruction with Bismuth level 2 or more.
b. Clinically non resectable
c. Total biliarubin =/> 2.0 mg/dL
d. No history of previous biliary stent placement
e. Expected prognosis > 3 months
f. Obtaining written informed concent

Key exclusion criteria

a. No tolerance of endoscopic procedures
b. ASA class 4 or more
c. Reconstructed upper GI tract
d. State after papillectomy, surgical biliojejunostomy
e. Planned for surgical resection, radiotherapy, PDT, or HIFU
f. Planned for scheduled replacement of PSs
g. State after placement of irremoval biliary stents
h. Tumors extending to lower bile duct
i. Tumors which have already invaded to broad area and which was considered to be difficult to treat with biliary drainage
j. Tumors with papillary growth
k. Active infectious inflammation
l. PSC, IgG4-SC and PBC
m. LC stage Child-Pugh C
n. Hemolyzing disease
o. Allergic for contrast

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Yoshihide
Middle name
Last name Kanno

Organization

Sendai City Medical Center

Division name

Department of Gastroenterology

Zip code

9810913

Address

5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan

TEL

022-252-1111

Email

yoshi-hk@openhp.or.jp


Public contact

Name of contact person

1st name Yoshihide
Middle name
Last name Kanno

Organization

Sendai City Medical Center

Division name

Department of Gastroenterology

Zip code

981-0913

Address

5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan

TEL

022-252-1111

Homepage URL


Email

yoshi-hk@openhp.or.jp


Sponsor or person

Institute

Sendai City Medical Center

Institute

Department

Personal name



Funding Source

Organization

Sendai City Medical Center

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

Institutional Review Board of Sendai City Medical Center

Address

Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan

Tel

0222521111

Email

yoshihk44@yahoo.co.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



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 24 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

Open public recruiting

Date of protocol fixation

2017 Year 01 Month 20 Day

Date of IRB

2017 Year 03 Month 01 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2021 Year 06 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 20 Day

Last modified on

2020 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name