UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic biliary radiofrequency ablation with multiple metal stents in patients with unresectable malignant hilar biliary stenosis: A multicenter prospective observation study
Acronym	Endoscopic biliary radiofrequency ablation with multiple metal stents
Scientific Title	Endoscopic biliary radiofrequency ablation with multiple metal stents in patients with unresectable malignant hilar biliary stenosis: A multicenter prospective observation study
Scientific Title:Acronym	Endoscopic biliary radiofrequency ablation with multiple metal stents
Region	Japan

Condition
Condition	patients with unresectable malignant hilar biliary stenosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of biliary radiofrequency ablation with multiple metal stents
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The success rate for the procedures of endoscopic biliary radiofrequency ablation with multiple metal stents
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	Endoscopic biliary radiofrequency ablation with multiple metal stents
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 malignant hilar stenosis 2.Patients who are scheduled for initial placement of multiple metal stents 3.The patient over the age of 20. 4.Written informed consent
Key exclusion criteria	1.Performance status 4 2.The patient has a severe comorbidity: American Society of Anesthesiologists classification from 3 to 5 3.The patient is pregnant or suspected pregnancy. 4.The patient cannot undergo duodenoscopic procedures such as a case with surgically altered anatomy or a case with a stenosis of gastrointestinal tract. 5.The patient received implantation of pacemaker. 6.The patient has a tendency to bleed. 7.The patient prohibited the participant of this study by their research investigator.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Hashimoto
Organization	Kagoshima University
Division name	Digestive and Lifestyle Diseases
Zip code	8908544
Address	8-35-1 Sakuragaoka, Kagoshima
TEL	0992755326
Email	kumdsh@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Shinichi Middle name Last name Hashimoto
Organization	Kagoshima University
Division name	Digestive and Lifestyle Diseases
Zip code	8908544
Address	8-35-1 Sakuragaoka, Kagoshima
TEL	0992755326
Homepage URL
Email	kumdsh@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Digestive and Lifestyle Diseases, Kagoshima University
Institute
Department

Funding Source
Organization	Digestive and Lifestyle Diseases, Kagoshima University
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	Ethics Committee on Clinical Research, Kagoshima University Hospital
Address	8-35-1 Sakuragaoka, Kagoshima
Tel	0992756692
Email	kufsyomu@kuas.kagoshima-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 04 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 16 Day
Date of IRB	2017 Year 05 Month 08 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2023 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	2017 Year 02 Month 16 Day
Last modified on	2021 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030078