UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025546
Receipt No. R000029401
Scientific Title Application of a micro guidewire to selective biliary cannulation in ERCP -Prospective randomized pilot trial-
Date of disclosure of the study information 2017/01/06
Last modified on 2019/07/09

* 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 Application of a micro guidewire to selective biliary cannulation in ERCP -Prospective randomized pilot trial-
Acronym Application of a micro guidewire to selective biliary cannulation in ERCP
Scientific Title Application of a micro guidewire to selective biliary cannulation in ERCP -Prospective randomized pilot trial-
Scientific Title:Acronym Application of a micro guidewire to selective biliary cannulation in ERCP
Region
Japan

Condition
Condition Obstructive jaundice
choledocholithiasis
biliary tract disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether a micro guidewire facilitate selective biliary cannulation in ERCP compared to a conventional guidewire
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Reduction of time and increase of success rate for selective biliary cannulation in ERCP
Key secondary outcomes safety,feasibility

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Interventions: 0.016 micro guidewire
Only use in ERCP
Interventions/Control_2 Control: 0.025 guidewire
Only use in 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Biliary diseases
Key exclusion criteria Patients with a history of endoscopic sphincterotomy and with papilla tumor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Mori
Organization Ichinomiya Nishi Hospital
Division name Gastroenterology
Zip code 4940001
Address 1 Hira Kaimei Ichinomiya Aichi Japan
TEL 0586-48-0077
Email a-mori@anzu.or.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Mori
Organization Ichinomiya Nishi Hospital
Division name Gastroenterology
Zip code 4940001
Address 1 Hira Kaimei Ichinomiya Aichi Japan
TEL 0586-48-0077
Homepage URL
Email a-mori@anzu.or.jp

Sponsor
Institute Gastroenterology Ichinomiya Nishi Hospital
Institute
Department

Funding Source
Organization Gastroenterology Ichinomiya Nishi Hospital
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 Ichinomiya Nishi Hospital
Address 1 Hira Kaimei Ichinomiya Aichi
Tel 0586480077
Email a-mori@anzu.or.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
2017 Year 01 Month 06 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
2017 Year 01 Month 06 Day
Date of IRB
2016 Year 11 Month 07 Day
Anticipated trial start date
2017 Year 01 Month 06 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 05 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029401

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.