UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007578 |
|---|---|
| Receipt number | 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 17:54:55 |
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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
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
maki.knk@gmail.com
Sponsor or person
Institute
Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008954
