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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007578
Receipt No. R000008954
Scientific Title Prospective, randomized comparative study in the capability of delineation between radial and curved linear array (convex) scanning EUS for pancreas and biliary duct: Radi-Con study
Date of disclosure of the study information 2012/03/27
Last modified on 2013/02/23

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Basic information
Public title Prospective, randomized comparative study in the capability of delineation between radial and curved linear array (convex) scanning EUS for pancreas and biliary duct: Radi-Con study
Acronym Radi-Con Study
Scientific Title Prospective, randomized comparative study in the capability of delineation between radial and curved linear array (convex) scanning EUS for pancreas and biliary duct: Radi-Con study
Scientific Title:Acronym Radi-Con Study
Region
Japan

Condition
Condition All indication cases for EUS
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the capability of delineation between radial and convex arrayed EUS, and evaluate clinical utility for convex arrayed EUS
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The capability of delineation for observational index


Key secondary outcomes Lesion detectability, Scope change rate, Examination time, With or without GI endoscopy study, amounts of sedative medicine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Examination by Radial EUS (GF-UE260)
Interventions/Control_2 Examination by Convex EUS (GF-UCT240, GF-UCT260)
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 All indication cases for Endoscopic ultrasound examination
Key exclusion criteria :Patients with previous surgery for upper digestive tract, pancreas, biliary tract

:Patients with gastrointestinal obstruction

:Patients without written informed consent

:Patients with severely impaired organ
function

:Patients considered ineligible for this
study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maki KANEKO
Organization Teine-Keijinkai Hospital
Division name Center for Gastroenterology
Zip code
Address 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Maki KANEKO
Organization Teine-Keijinkai Hospital
Division name Center for Gastroenterology
Zip code
Address
TEL
Homepage URL
Email maki.knk@gmail.com

Sponsor
Institute Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department

Funding Source
Organization Center for Gastroenterology, Teine-Keijinkai 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
Address
Tel
Email

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 手稲渓仁会病院(北海道)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 27 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
2011 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 31 Day
Date trial data considered complete
2011 Year 12 Month 31 Day
Date analysis concluded
2012 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 27 Day
Last modified on
2013 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008954

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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