UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001388
Receipt number 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 17:51:59

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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 or person

Institute

Department of Gastroenterology
Aichi Cancer Center Hospital

Institute

Department

Personal name



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

Value
https://center6.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