UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041343 |
|---|---|
| Receipt number | R000047201 |
| Scientific Title | Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/02/26 16:47:41 |
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Basic information
Public title
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial
Acronym
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography for malignant distal bile duct obstruction: A multicenter randomized controlled trial
Scientific Title
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial
Scientific Title:Acronym
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography for malignant distal bile duct obstruction : A multicenter randomized controlled trial
Region
| Japan |
Condition
Condition
A malignant distal biliary obstruction that is unresectable or presents a very high surgical risk
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare first-line biliary drainage for malignant distal bile duct obstrucion between ultrasonic endoscopic biliary drainage and transpapillary biliary drainage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Stent patency rate at 180 days after treatment
Key secondary outcomes
Procedure success rate, clinical improvement rate, incident rate, procedure time, success rate of re-intervention, rate of successful stenting without dilatation (EUS-BD group only), survival time, and percentage of post-drainage chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transpapillary biliary drainage (ERCP)
Interventions/Control_2
Endoscopic ultrasound biliary drainage (EUS-BD)
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) 20 years old or over
2) Radiological diagnosis (with or without pathological confirmation) of malignancy, and presence of a malignant distal biliary obstruction and dilation of the upstream bile duct that is unresectable or presents a very high surgical risk
3) Written consent obtained following adequate explanation of the study aims, design, and procedures.
Key exclusion criteria
1) Radiological evidence of gastric outlet obstruction on CT,
2) Hilar biliary obstruction,
3) Surgically altered anatomy
4) ECOG performance status of 4,
5) Poorly controlled ascites,
6) History of endoscopic sphincterotomy (EST),
7) Biliary stenting,
8) Serious complication involving another organ,
9) Uncorrectable coagulopathy and/or thrombocytopenia,
10) Any other condition or situation determined by a study investigator to represent a reason for ineligibility.
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama-Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama city
TEL
073-441-0627
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Itonaga |
Organization
Wakayama-Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama city
TEL
073-441-0627
Homepage URL
kitano@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama-Medical University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Wakayama Medical University
Address
Kimiidera 811-1, Wakayama city
Tel
0734472300
wa-rinri@wakayama-med.ac.jp
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
| 2020 | Year | 09 | Month | 01 | 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
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2021 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047201
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
