UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034036
Receipt number R000038800
Scientific Title Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
Date of disclosure of the study information 2018/09/10
Last modified on 2019/09/06 09:07:33

* 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

Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction

Acronym

RCT of IS and MS-SBS for MHBO

Scientific Title

Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction

Scientific Title:Acronym

RCT of IS and MS-SBS for MHBO

Region

Japan


Condition

Condition

malignant hilar biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the technical success, time to recurrent biliary obstruction, or re-intervention after recurrent biliary obstruction between inside stenting using plastic stent and side by side stenting using full-covered self expandable metallic stent

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to Recurrent Biliary Obstruction

Key secondary outcomes

technical success rate, procedure time, functional success rate, adverse event, time of possible biliary drainage including re-intervention, survival time


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

side by side stenting using 6mm full-covered self expandable metallic stent

Interventions/Control_2

inside stenting using plastic stent

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. Untreated unresectable malignant hilar biliary obstruction
2. Type 2/3/4 in Bismuth classification
3. More than 3mg/dl of serum bilirubin
4. More than 20 years old
5. More than 30 days of expected survival period
6. Written informed consent obtained

Key exclusion criteria

1. Patients with surgical altered anatomy or post-hepatectomy
2. Endoscopic approach to the biliary system is impossible
3. Prior biliary drainage (transient naso-biliary drainage can be included)
4. biliary obstruction to 3rd branch of bilateral bile duct
5. Pregnant women or those suspected of pregnancy
6. Patients considered ineligible by attending physicians

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Toshifumi
Middle name
Last name Kin

Organization

Teine-Keijinkai Hospital

Division name

Center for Gastroenterology

Zip code

006-8555

Address

1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan

TEL

011-681-8111

Email

kin_toshifumi@yahoo.co.jp


Public contact

Name of contact person

1st name Toshifumi
Middle name
Last name Kin

Organization

Teine-Keijinkai Hospital

Division name

Center for Gastroenterology

Zip code

006-8555

Address

1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan

TEL

011-681-8111

Homepage URL


Email

kin_toshifumi@yahoo.co.jp


Sponsor or person

Institute

Center for Gastroenterology, Teine-Keijinkai Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Teine-Keijinkai Hospital

Address

1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan

Tel

011-681-8111

Email

teine@keijinkai.or.jp


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 09 Month 10 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

Open public recruiting

Date of protocol fixation

2018 Year 08 Month 22 Day

Date of IRB


Anticipated trial start date

2018 Year 09 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

2018 Year 09 Month 05 Day

Last modified on

2019 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name