UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022101
Receipt number R000025476
Scientific Title Evaluation of the efficacy of endoscopic ultrasound-guided bile duct drainage in patients with surgically altered anatomies: a prospective multicenter registration study.
Date of disclosure of the study information 2016/06/01
Last modified on 2016/04/27 13:39:03

* 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

Evaluation of the efficacy of endoscopic ultrasound-guided bile duct drainage in patients with surgically altered anatomies: a prospective multicenter registration study.

Acronym

Evaluation of the efficacy of EUS-BD in patients with surgically altered anatomies

Scientific Title

Evaluation of the efficacy of endoscopic ultrasound-guided bile duct drainage in patients with surgically altered anatomies: a prospective multicenter registration study.

Scientific Title:Acronym

Evaluation of the efficacy of EUS-BD in patients with surgically altered anatomies

Region

Japan


Condition

Condition

Cases with malignant biliary obstruction after surgically altered anatomy

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of endoscopic ultrasound-guided biliary drainage in patients with malignant biliary obstruction after surgically altered anatomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Technical success rate of endoscopic ultrasound-guided biliary drainage

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with surgically altered anatomy (Roux-en-Y reconstruction)
2)Patients with unresectable malignant biliary obstruction
3)Patients consent to be included in this study based on his/her own free will after sufficient informing and understanding of the study

Key exclusion criteria

1)Patients who cannot undergo endoscopic procedures
2)Patients whose performance status are 4
3)Patients with sever complication in other organs except original disease
4)Patients whose life prognosis are expected shorter than 3 months
5)Cases judged by principal investigator to be unsuitable as subjects

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Kitano

Organization

Kindai University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka

TEL

072-366-0221

Email

m-kitano@med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kosuke Minaga

Organization

Kindai University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka

TEL

072-366-0221

Homepage URL


Email

kousukeminaga@med.kindai.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

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

2016 Year 06 Month 01 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

2016 Year 02 Month 22 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observational study (cohort study)

This study aims to evaluate the efficacy and safety of endoscopic-ultrasound guided biliary drainage (EUS-BD) with malignant biliary obstruction after surgically altered anatomy
The primary outcome is the technical success rate of EUS-BD. The secondary outcomes are clinical success rate, procedure time, adverse events, and stent patency 3 months after EUS-BD.

The target of this study is a patient with unresectable biliary obstruction after surgically altered anatomy visited participating institutions between 2016 May and 2018 May.


Management information

Registered date

2016 Year 04 Month 27 Day

Last modified on

2016 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name