UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026538
Receipt number R000030476
Scientific Title Multicenter prospective study of feasibility and safety of radio frequency ablation for malignant biliary stricture under ERCP guidance
Date of disclosure of the study information 2017/03/14
Last modified on 2017/03/14 07:00:18

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Basic information

Public title

Multicenter prospective study of feasibility and safety of radio frequency ablation for malignant biliary stricture under ERCP guidance

Acronym

Multicenter prospective study of feasibility and safety of radio frequency ablation under ERCP guidance

Scientific Title

Multicenter prospective study of feasibility and safety of radio frequency ablation for malignant biliary stricture under ERCP guidance

Scientific Title:Acronym

Multicenter prospective study of feasibility and safety of radio frequency ablation under ERCP guidance

Region

Japan


Condition

Condition

Malignant biliary stricture

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Technical feasibility and safety

Basic objectives2

Others

Basic objectives -Others

Stent patency

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Technical feasibility and safety

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Radiofrequency ablation

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

Over 20years old
Malignant biliary stricture
Complicated with obstructive jaundice and advanced malignant tumor
Possibility of over 3months prognosis
PS0 to 2

Key exclusion criteria

Patient's rejection

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Ogura

Organization

Osaka Medical College

Division name

2nd Department of Internal Medicine

Zip code


Address

2-7 Daigakuchou, Takatsukishi, Osaka 569-8686, Japan

TEL

072-683-1221

Email

oguratakeshi0411@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Ogura

Organization

Osaka Medical College

Division name

2nd Department of Internal Medicine

Zip code


Address

2-7 Daigakuchou, Takatsukishi, Osaka 569-8686, Japan

TEL

072-683-1221

Homepage URL


Email

oguratakeshi0411@yahoo.co.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College

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

2017 Year 03 Month 14 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

Date of protocol fixation

2007 Year 02 Month 14 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 14 Day

Last modified on

2017 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name