UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014579
Receipt number R000016957
Scientific Title A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for recurrent obstruction of covered metal stent for distal malignant biliary obstruction
Date of disclosure of the study information 2014/07/22
Last modified on 2016/07/17 20:28:26

* 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

A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for recurrent obstruction of covered metal stent for distal malignant biliary obstruction

Acronym

ARMS as a reintervention

Scientific Title

A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for recurrent obstruction of covered metal stent for distal malignant biliary obstruction

Scientific Title:Acronym

ARMS as a reintervention

Region

Japan


Condition

Condition

Nonresectable distal malignant biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare antireflux metal stent and conventional covered metal stent for recurrent occlusion of conventional covered metal stent as a result of sludge or food impaction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to recurrent biliary obstrution after the placement of metal stent

Key secondary outcomes



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

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Endoscopic placement of antireflux metal stent for biliay obstruction

Interventions/Control_2

Endoscopic placement of conventional covered metal stent for biliay obstruction

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. nonresectable malignant biliary obstruction
2. distal biliary obstruction (2 cm or longer from the bifurcation)
3. Covered metal stent was occluded due to the duodenobiliary reflux within 90 days of stent placement, and cholantitis subsided via endoscopic biliary drainage
4. Irrespective of sex and a primary disease
5. Written informed consent obtained

Key exclusion criteria

1. Endoscopic approach to the biliary system is impossible
2. Hilar biliary obstruction
3. Performance status is four
4. Gastrointestinal obstruction distal to the papilla (patients whose gastrointestinal obstruction was resolved via a stent or surgical bypass can be included)
5. Severe comobidities in other organs
6. Pregnant women or those suspected of pregnancy
7. Written informed consent not obtained
8. Patients considered ineligible by attending physicians

Target sample size

66


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Isayama

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastroenterology,

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

+81-3-3815-5411

Email

isayama-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Isayama

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastroenterology,

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

+81-3-3815-5411

Homepage URL


Email

isayama-tky@umin.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Century Medical, Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

2014 Year 07 Month 22 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

Terminated

Date of protocol fixation

2014 Year 06 Month 26 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 06 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

2014 Year 07 Month 17 Day

Last modified on

2016 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016957


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name