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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001388
Receipt No. R000001687
Scientific Title Phase II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment of patients with malignant biliary obstruction
Date of disclosure of the study information 2008/09/23
Last modified on 2009/12/21

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Basic information
Public title Phase II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment of patients with malignant biliary obstruction
Acronym Phase II study of EUS-guided choledochoduodenostomy for biliary drainage
Scientific Title Phase II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment of patients with malignant biliary obstruction
Scientific Title:Acronym Phase II study of EUS-guided choledochoduodenostomy for biliary drainage
Region
Japan

Condition
Condition Malignant biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the safety and efficacy of endoscopic ultrasound-guided choledochoduodenostomy for malignant biliary obstruction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Grade and incidence of adverse events
Rate of successful completion of procedure
Key secondary outcomes patency period of stent

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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 (EUS-CDS) was approached from the first portion of the duodenum using a convex echoendoscope and a needle knife. Second steps of the procedure are passage dilatation and the plastic stent placement. All procedures were performed through the accessory channel of the echoendoscope over the guide wire.
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. Biliary obstruction induced by malignant tumor
2. Non-resectable tumor
3. Major organ preserved
4. Performance status (ECOG) is 0-3
Key exclusion criteria 1. Obstruction of upper GI tract
2. Obstruction of upper part of extrahepatic biliary duct
3. History or schedule of radiotherapy for duodenum
4. Inappropriate for this trial by doctors
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Yamao
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1 Kanokoden Chikusa-ku Nagoya, Japan
TEL 052-762-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Sawaki
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1 Kanokoden Chikusa-ku Nagoya, Japan
TEL 052-762-6111
Homepage URL
Email asawaki@aichi-cc.jp

Sponsor
Institute Department of Gastroenterology
Aichi Cancer Center Hospital
Institute
Department

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
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
2008 Year 09 Month 23 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
2008 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 09 Month 23 Day
Last modified on
2009 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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