UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy of endoscopic ultrasound-guided bile duct drainage in patients with surgically altered anatomies: a prospective multicenter registration study.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masayuki Kitano
Organization	Kindai University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
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	Kosuke Minaga
Organization	Kindai University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Homepage URL
Email	kousukeminaga@med.kindai.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025476