UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025847
Receipt number 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 20:40:31

* 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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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