UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025847
Receipt No. R000029721
Scientific Title Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study
Date of disclosure of the study information 2017/01/25
Last modified on 2017/01/25

* 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 Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study
Acronym Endobiliary radiofrequency ablation for malignant biliary strictures
Scientific Title Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study
Scientific Title:Acronym Endobiliary radiofrequency ablation for malignant biliary strictures
Region
Asia(except Japan)

Condition
Condition Malignant biliary strictures by bile duct cancer, gallbladder cancer, or pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the safety and efficacy of endobiliary radiofrequency ablation (RFA) by using a new catheter in patients with malignant biliary strictures.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of early adverse events within 30 days after endobiliary radiofrequency such as hemobilia, bile duct perforation, pancreatitis, bleeding, cholangitis, perforation, or cholecystitis.
Key secondary outcomes Late adverse events after 30 days after endobiliary radiofrequency, stent patency of biliary metallic stent after endobiliary radiofrequency ablation, and patient survival after endobiliary radiofrequncy ablation.

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
Other
Interventions/Control_1 Endobiliary radiofrequency ablation by using a new catheter and biliary metallic stenting through ERCP
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
19 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) More than 19 in age
2) Extrahepatic malignant biliary stricture that was histophathologically or clinically confirmed
3)Unresectable or inoperable due to comorbidity or refusal of operation
4) More than 3 months of predictive survival
Key exclusion criteria 1) Contraindications for ERCP
2) Uncontrolled coagulopathy: PT-INR > 1.5 (normal 0.85 - 1.25) or platelet count < 60,000/mm3 (normal 150,000 - 450,000/mm3)
3) Previously operation of bile duct
4) Impossible to access to the ampulla of Vater or failed selective biliary cannulation
5) Pregnant or breastfeeding women
6) Refusal to the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hyun Jong Choi
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address 170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL +82-32-621-5211
Email joseph@schmc.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Hyun Jong Choi
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address 170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL +82-32-621-5211
Homepage URL
Email joseph@schmc.ac.kr

Sponsor
Institute Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine
Institute
Department

Funding Source
Organization Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 25 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
Date of protocol fixation
2016 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 25 Day
Last modified on
2017 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029721

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.