UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective multicenter study of EUS-guided choledochoduodenostomy for unresectable malignant biliary obstruction
Title of the study (Brief title)	EUS-guided choledochoduodenostomy for unresectable malignant biliary obstruction
Region	Japan

Condition
Condition	Patients with unresectable malignant distal biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of EUS-guided choledochoduodenostomy as a first line treatment for unresectable malignant distal biliary obstruction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Techinical success
Key secondary outcomes	complications, stent patency

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	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EUS-guided choledochoduodenostomy
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. unresectable malignant distal biliary obstruction without prior drainage 2. Age >= 20 y.o. 3. Serum T.Bil >=2.0 mg/dL 4. ECOG Performance Status 0-2 5. Informed consent
Key exclusion criteria	1. Ascites 2. Prior gastric surgery 3. Biliary obstruction within 2 cm from hepatic hilum 4. Failure to detect CBD on EUS 5. Patients on anticoagulant or antiplatelet medications 6. Coagulopathy (Platlet < 50,000 or PT-INR >=2) 7. Severe comorbidity 8. Failed informed consent 9. Patients considered to be inadequate for clinical trials
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroyuki Isayama
Organization	The University of Tokyo
Division name	Department of Gastroenterology, Graduate School of Medicine
Address	7-3-1, Hongo, Bunkyo-ku Tokyo
TEL	03-3815-5411
Email	isayama-tky@umin.ac.jp

Public contact
Name of contact person	Yousuke Nakai
Organization	The University of Tokyo
Division name	Department of Gastroenterology, Graduate School of Medicine
Address	7-3-1 Hongo Bunkyoku Tokyo
TEL	03-3815-5411
Homepage URL
Email	ynakai-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo, Department of Gastroenterology
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	None
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 01 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 25 Day
Anticipated trial start date	2013 Year 01 Month 09 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 09 Day
Last modified on	2016 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010656