UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051386