UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic radiofrequency ablation combined with metal stent placement for malignant biliary obstruction in patients with surgically altered anatomy
Title of the study (Brief title)	Endoscopic radiofrequency ablation combined with metal stent placement for malignant biliary obstruction in patients with surgically altered anatomy
Region	Japan

Condition
Condition	Unresectable malignant biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of RFA combined with metal stent placement using balloon enteroscope for malignant biliary obstruction in patients with surgically altered anatomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patient with unrsectable malignat biliary obstruction and surgically altered anatomy which require biliary stent placement using balloon enteroscope
Key exclusion criteria	1) Patients with severe comorbidity in any other organs 2) Patients of Performance Status 4 3) Patients having difficulty in balloon enteroscopy 4) Patients having difficulty in endoscopic RFA 5) Pregnant women or those suspected of pregnancy 6) Patients without informed consent 7) Inappropriate patients for entry on this study in the judgement of their research investigator
Target sample size	15

Research contact person
Name of lead principal investigator	Tadahisa Inoue
Organization	Aichi Medical University
Division name	Department of Gastroenterology
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561-62-3311
Email	tinoue-tag@umin.ac.jp

Public contact
Name of contact person	Tadahisa Inoue
Organization	Aichi Medical University
Division name	Department of Gastroenterology
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561-62-3311
Homepage URL
Email	tinoue-tag@umin.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 08 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 13 Day
Anticipated trial start date	2018 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observational study

Management information
Registered date	2018 Year 08 Month 30 Day
Last modified on	2018 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038512