UMIN-CTR Clinical Trial

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

Malignant biliary stricture

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

千葉大学医学部附属病院（千葉県）Chiba University Hospital

Date of disclosure of the study information

2018

Year

03

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

03

Month

06

Day

Last modified on

2019

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036026