UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003635 |
|---|---|
| Receipt number | R000004406 |
| Scientific Title | Phase I/II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment (using metallic stent)of patients with malignant biliary obstruction |
| Date of disclosure of the study information | 2010/05/18 |
| Last modified on | 2011/11/21 09:03:12 |
* 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
Phase I/II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment (using metallic stent)of patients with malignant biliary obstruction
Acronym
PhaseI/II study of EUS-guided choledochoduodenostomy for biliary drainage(using metallic stent)
Scientific Title
Phase I/II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment (using metallic stent)of patients with malignant biliary obstruction
Scientific Title:Acronym
PhaseI/II study of EUS-guided choledochoduodenostomy for biliary drainage(using metallic stent)
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
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 I,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 metallic 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
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Hara |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1 Kanokoden Chikusa-ku Nagoya, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
0527626111
Homepage URL
khara@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 05 | Month | 18 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 18 | Day |
Last modified on
| 2011 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004406
