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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016227
Receipt No. R000018829
Scientific Title Estimation of microcirculation using contrast-ehanced harmonic endoscopic ultrasonography for diagnosing solid lesions in the pancreas: A multicenter cohort study,
Date of disclosure of the study information 2015/01/15
Last modified on 2017/08/18

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Basic information
Public title Estimation of microcirculation using contrast-ehanced harmonic endoscopic ultrasonography for diagnosing solid lesions in the pancreas: A multicenter cohort study,
Acronym Estimation of microcirculation using contrast-ehanced harmonic endoscopic ultrasonography for diagnosing solid lesions in the pancreas: A multicenter cohort study,
Scientific Title Estimation of microcirculation using contrast-ehanced harmonic endoscopic ultrasonography for diagnosing solid lesions in the pancreas: A multicenter cohort study,
Scientific Title:Acronym Estimation of microcirculation using contrast-ehanced harmonic endoscopic ultrasonography for diagnosing solid lesions in the pancreas: A multicenter cohort study,
Region
Japan

Condition
Condition Pancreatic tumors
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to assess diagnostic abilities of tissue harmonic endoscopic ultrasonography, contrast-enhanced harmonic endoscopic ultrasonography (Ex-PHD-CHE) and contrast-enhanced harmonic endoscopic ultrasonography (Ex-PHD-THE), and to compare these values between three imaging methods.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess assess diagnostic abilities of tissue harmonic endoscopic ultrasonography, contrast-enhanced harmonic endoscopic ultrasonography (Ex-PHD-CHE) and contrast-enhanced harmonic endoscopic ultrasonography (Ex-PHD-THE), and to compare these values between three imaging methods.
Key secondary outcomes To evaluate reproducibility of contrast-enhanced harmonic endoscopic ultrasonography(Ex-PHD-THE).
To compare diagnostic ability in diagnosing pancreatic tumors between contrast-enhanced harmonic endoscopic ultrasonography(Ex-PHD-THE)and MDCT.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 contrast-enhanced harmonic endoscopic ultrasonography
Interventions/Control_2
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
100 years-old >
Gender Male and Female
Key inclusion criteria Pancreatic mass of 3cm or less to be depicted by conventional endoscopic ultrasonography
Written informed consent
ECOG performance status = 0-2
Key exclusion criteria Inapropriate to perform endoscopic ultrasonography
Impossible to perform endoscopy
Surgically altered digestive tract
Failure of other organs (ASA: Grade 3, 4)
Allergy to iodine or eggs
Renal failure
Inability to obtain informed consent
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Faculty of Medicine
Division name Department of gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Email m-kitano@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Homepage URL
Email m-kitano@med.kindai.ac.jp

Sponsor
Institute study Group for Contrast-enhanced Harmonic Endoscopic Ultrasonography
Institute
Department

Funding Source
Organization The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization Non profit foundation
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 東北大学医学部附属病院(宮城県)、横浜市立大学総合医療センター(神奈川県)、山梨大学医学部附属病院(山梨県)、大阪府立成人病センター(大阪府)、近畿大学医学部附属病院(大阪府)、神戸大学医学部附属病院(兵庫県)、岡山大学医学部附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 15 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
2014 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 15 Day
Last modified on
2017 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018829

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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