UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory survey of the safety and efficacy of endoscopic radiofrequency ablation for malignant biliary stricture
Acronym	Endoscopic radiofrequency ablation for malignant biliary stricture
Scientific Title	Exploratory survey of the safety and efficacy of endoscopic radiofrequency ablation for malignant biliary stricture
Scientific Title:Acronym	Endoscopic radiofrequency ablation for malignant biliary stricture
Region	Japan

Condition
Condition	Malignant biliary stricture
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Exploratory survey of the safety and efficucy of endoscopic radiofrequency ablation for malignant biliary stricture
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Serious adverse event incidence
Key secondary outcomes	Procedure completion rate Evaluation of malignant biliary stricture diameter and stenosis length in retrograde cholangiography (before and after treatment) Evaluation of cauterization range using Dynamic CT Biliary stent patent term Overall survival Adverse event incidence (post-bleeding rate, cholangitis incidence rate, pancreatitis incidence rate, fever incidence rate, abdominal pain incidence rate)

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	Perform endoscopic radiofrequency ablation therapy for malignant biliary stricture patients requiring biliary duct drainage before biliary stent placement
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 biliary stricture due to malignant disease and requiring biliary duct drainage 2) Patients with malignancy diagnosed pathologically or radiologically / endoscopically 3) Patients who are surgically inoperable or are not surgically applied 4) Patients who are over 20 years of age at the time of consent acquisition 5) Patients who do not take anticoagulants, antiplatelet drugs or patients who can be discontinued before the study treatment 6) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding
Key exclusion criteria	1) Patients with malignant biliary stricture due to lymph node metastasis 2) Patient with pacemaker or defibrillator inserted 3) Patients who are unlikely to have a prognosis for 1 month 4) Patients with performance status 2 or higher 5) Patients who can not control bleeding tendency (PTINR 1.5 or more, platelet number 50,000 or less). 6) Patients with duodenal stenosis, obstruction that may affect biliary excretion 7) Patients who are pregnant, have a possibility of pregnancy, are within 28 days after birth, or who are breastfeeding 8) Patients with history of upper gastrointestinal surgical resection 9) Patients who have impaired renal function and can not perform contrast CT 10) Patients in which a bile duct metal stent has already been placed
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoya Kato
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Gastroenterology
Zip code
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-43-226-2083
Email	kato.naoya@chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Harutoshi Sugiyama
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Gastroenterology
Zip code
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-43-226-2083
Homepage URL
Email	sugiharu_food@yahoo.co.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	SHIONOGI & CO., LTD. Boston Scientific Japan Co., Ltd. Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	千葉大学医学部附属病院（千葉県）Chiba University Hospital

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 12 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	2017 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2021 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	2018 Year 03 Month 06 Day
Last modified on	2019 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036026

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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