UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044973
Receipt number R000051386
Scientific Title A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis
Date of disclosure of the study information 2021/07/27
Last modified on 2021/07/27 21:22:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis

Acronym

Safety of endobiliary RFA for hilar malignant biliary stenosis

Scientific Title

A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis

Scientific Title:Acronym

Safety of endobiliary RFA for hilar malignant biliary stenosis

Region

Japan


Condition

Condition

hilar malignant biliary stenosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify the safety of endoscopic radiofrequency ablation of hilar malignant biliary stenosis.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse events

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 Maneuver

Interventions/Control_1

endobiliary 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

1. Unresectable malignant hilar biliary obstruction with pathological proof
2.Bismuth classification 2,3,4
3.ECOG performance status 0-3
4.Given written informed consent

Key exclusion criteria

1.Patients in whom the endoscope cannot reach the duodenal papilla
2.Patients with jaundice or cholangitis that cannot be controlled by biliary drainage
3.Patients with serious complications in other organs: ASA classification of 3 or higher
4.Patients with a life expectancy of less than 3 months
5.Patients with a history of surgical gastrointestinal reconstruction
6.Patients with significant invasion of the hepatic artery by the tumor
7.Patients who are deemed inappropriate by the researcher

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Arata
Middle name
Last name Sakai

Organization

Kobe University Hospital

Division name

Division of gastroenterology, Department of Internal medicine

Zip code

6500017

Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

TEL

+81-78-382-5774

Email

asakai@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Arata
Middle name
Last name Sakai

Organization

Kobe University Hospital

Division name

Division of gastroenterology, Department of Internal medicine

Zip code

650-0017

Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

TEL

+81-78-382-5774

Homepage URL


Email

asakai@med.kobe-u.ac.jp


Sponsor or person

Institute

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate school of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate school of Medicine

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

kobe University IRB office

Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

Tel

078-382-6669

Email

kainyu@med.kobe-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

2021 Year 07 Month 27 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

Preinitiation

Date of protocol fixation

2021 Year 07 Month 27 Day

Date of IRB


Anticipated trial start date

2021 Year 09 Month 01 Day

Last follow-up date

2023 Year 08 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

2021 Year 07 Month 27 Day

Last modified on

2021 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051386


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name