UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031110
Receipt number R000034361
Scientific Title Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma
Date of disclosure of the study information 2019/01/01
Last modified on 2021/02/03 23:30:03

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Basic information

Public title

Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma

Acronym

Large-bore metal stent study (LBM study)

Scientific Title

Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma

Scientific Title:Acronym

Large-bore metal stent study (LBM study)

Region

Japan


Condition

Condition

Unresectable pancreatic cancer with malignant biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the patency and safety of Fully-covered, large-bore metal stent for unresectable pancreatic cancer with distal biliary obstruction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Time to stent dysfunction

Key secondary outcomes

Effectiveness
1) Stent patency period
2) Survival period
3) Event free survival
4) Stent patency period after reintervention
5) Time to stent dysfunction after reintervention
6) Cost effectiveness

Safety
1) Early complications
2) Late complications
3) Technical success rate
4) Removability of the stent
5) Removability of the second stent


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

New designed large-bore, fully covered self-expandable metallic stent

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with unresectable pancreatic cancer with distal malignant biliary obstruction.
2) Patients with predictable prognosis of more than 4 months.
3) Patients with written informed consent.
4) Patients with performance status 0-3.

Key exclusion criteria

1) Patients with massive ascites.
2) Patients with severely impaired organ function.
3) Patients for whom endoscopic biliary drainage is difficult.
4) Patients with duodenal obstruction.
5) Patients whose antithrombotic drugs cannot be stopped.
6) Patients considered ineligible for this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Kurita

Organization

Kitano Hospital, Tazuke Kofukai Medical Research Institute

Division name

Department of Gastroenterology and Hepatology

Zip code

530-8480

Address

2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan

TEL

06-6312-8831

Email

kuritaaki1976@gmail.com


Public contact

Name of contact person

1st name Akira
Middle name
Last name Kurita

Organization

Kitano Hospital, Tazuke Kofukai Medical Research Institute

Division name

Department of Gastroenterology and Hepatology

Zip code

530-8480

Address

2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan

TEL

06-6312-8831

Homepage URL


Email

kuritaaki1976@gmail.com


Sponsor or person

Institute

Kitano Hospital, Tazuke Kofukai Medical Research Institute

Institute

Department

Personal name



Funding Source

Organization

None

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

Kitano Hospital, Tazuke Kofukai Medical Research Institute

Address

2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan

Tel

06-6312-8831

Email

rinshou@kitano-hp.or.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

2019 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

10

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

No longer recruiting

Date of protocol fixation

2017 Year 12 Month 13 Day

Date of IRB

2017 Year 12 Month 13 Day

Anticipated trial start date

2018 Year 02 Month 12 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 04 Month 01 Day

Date analysis concluded

2024 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 01 Day

Last modified on

2021 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034361


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name