UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036054 |
|---|---|
| Receipt number | R000041068 |
| Scientific Title | Randamized contral study of EUSintervention and Balloon Enteroscopy Assisted ERCP for The Management of Bile Duct Stones in Patients with gastric resection and Roux-en-Y Reconstruction |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2023/09/12 06:22:08 |
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Basic information
Public title
Randamized contral study of EUSintervention and Balloon Enteroscopy Assisted ERCP for The Management of Bile Duct Stones in Patients with gastric resection and Roux-en-Y Reconstruction
Acronym
RCT of EUS-intervention and e-ERCP for CBD stones in patients with gastric resection and R-Y Reconstruction
Scientific Title
Randamized contral study of EUSintervention and Balloon Enteroscopy Assisted ERCP for The Management of Bile Duct Stones in Patients with gastric resection and Roux-en-Y Reconstruction
Scientific Title:Acronym
RCT of EUS-intervention and e-ERCP for CBD stones in patients with gastric resection and R-Y Reconstruction
Region
| Japan |
Condition
Condition
common bile duct stones with gastrectomy and Roux-en-Y reconstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
EUS-intervention therapy is useful for obstructive jaundice and attention as a new therapy for biliary disease. In particular, EUS intervention was reported to be useful for the case that is difficult for ERCP.
The Management of Bile Duct Stones in Patients with Surgically-Altered Anatomy is unclear. We will examine the usefulness, safety and treatment outcomes of EUS intervention therapy and ballon enteroscopy assisted ERCP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of complete stone removal at 1st session
Key secondary outcomes
The success rate of complete stone removal
The success rate of technical success
The rate of adverse events
The procedure time
The hospital stay days
The number of session for complete stone removal
The recurrence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-intervention
Interventions/Control_2
balloon enteroscopy assisted ERCP
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 age over 20
2 The patients with gastrectomy and R-Y construction
3 CBD stone was detected
4 The patients had informed consent.
Key exclusion criteria
1 Performance status 4
2 The stones are right hepatic bile duct
3 The tendency of Bleeding(Plt<50000/mm3,PT-INR>1.5)
4 The patients had Antithrombotic drugs.
5 pregnancy patients
6 The past histry of ballon enteroscopy assisted ERCP or EUS-intervention.
7 The patients that the doctors though unsuitable
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Juntendo university
Division name
Department of Gastroenterology
Zip code
1138421
Address
Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
h-isayama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | YUSUKE |
| Middle name | |
| Last name | TAKASAKI |
Organization
Juntendo university
Division name
Department of Gastroenterology
Zip code
1138421
Address
Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ytakasa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
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
Juntendo university
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2019 | Year | 03 | Month | 11 | 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
Suspended
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041068
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| Registered date | File name |
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