UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024832
Receipt number R000028568
Scientific Title A Multicenter Prospective Randomized Study of Fully Covered Metallic Stent versus Tube Stent in Patients with Borderline Resectable Pancreatic Carcinoma
Date of disclosure of the study information 2017/01/01
Last modified on 2019/05/19 15:50:31

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Basic information

Public title

A Multicenter Prospective Randomized Study of Fully Covered Metallic Stent versus Tube Stent in Patients with Borderline Resectable Pancreatic Carcinoma

Acronym

TOBIP-01/NUPAT-04

Scientific Title

A Multicenter Prospective Randomized Study of Fully Covered Metallic Stent versus Tube Stent in Patients with Borderline Resectable Pancreatic Carcinoma

Scientific Title:Acronym

TOBIP-01/NUPAT-04

Region

Japan


Condition

Condition

Pancreatic carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Compare of stent patency between tube stent and fully covered metallic stent for BR pancreatic carcinoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of cases who do not need stent exchange until surgical operation or diagnosis of inoperation

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

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

tube stent (more than 8.5 Fr)

Interventions/Control_2

Fully covered metallic stent (more than 8 mm)

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Borderline resectable Pancreatic ductal carcinoma case with bile duct stenosis (image diagnosis)
Cases planed NAC(R)T more than 2 month
PS(ECOG) 0 or 1
Adequate oral intake
Estimated life expectancy more than 3 months
Without another malignant disease
With informed concent

Key exclusion criteria

Severe neurologic impairment or mental disorder
With severe other organ disorder
Pregnant or lactating women,

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yoshiki
Middle name
Last name Hirooka

Organization

Nagoya University Hospital

Division name

Department of Endoscopy

Zip code

4668550

Address

65 Tsurumai-cho Showa-ku Nagoya

TEL

0527442166

Email

h-kawa@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Hiroki
Middle name
Last name Kawashima

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

4668550

Address

65 Tsurumai-cho Showa-ku Nagoya

TEL

0527442166

Homepage URL


Email

h-kawa@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Boards of Nagoya University Hospital

Address

65 Tsuruma-cho, Showa-ku, Nagoya, Japan

Tel

0527442061

Email

ethics@med.nagoya-u.ac.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 01 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

Open public recruiting

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 04 Month 01 Day

Anticipated trial start date

2017 Year 03 Month 29 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 14 Day

Last modified on

2019 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028568


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name