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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036054
Receipt No. 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 2019/09/01

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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 80

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
Email 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
Email ytakasa@juntendo.ac.jp

Sponsor
Institute Juntendo university
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 Juntendo university
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-5802-1584
Email 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 Enrolling by invitation
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
2022 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
2019 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041068

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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