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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009285
Receipt No. R000008873
Scientific Title Usefulness and limits of transabdominal ultrasonography for pancreatic diseases
Date of disclosure of the study information 2012/11/08
Last modified on 2013/12/12

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Basic information
Public title Usefulness and limits of transabdominal ultrasonography for pancreatic diseases
Acronym Usefulness and limits of transabdominal ultrasonography for pancreatic diseases
Scientific Title Usefulness and limits of transabdominal ultrasonography for pancreatic diseases
Scientific Title:Acronym Usefulness and limits of transabdominal ultrasonography for pancreatic diseases
Region
Japan

Condition
Condition Biliary tract system and pancreas disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness and limits of transabdominal ultrasonography for pancreatic diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To clarify the limits of transabdominal ultrasonography for pancreatic unobservable area
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients with biliary or pancreatic disease performed MDCT or EUS at Nagoya University Hospital.
2)Patients with MDCT or EUS within three months.
3)20-80 years of age.
4)Performance Status 0-1.
5)no sever organ dysfunction.
6)Patients who provided written informed consent.
Key exclusion criteria 1)uncontrolable infection.
2)Case having the sever drug allergy including contrast.
3)Patients with liver cirrhosis, splenomegalia,ascites.
4)Patients with a pacemaker, implantable cardioverter-defibrillator.
5)Post abdominal surgery
6)Difficulty with receiving examination.
7)Patinets with sever impairment.
8)Possibility of the pregnancy
9)Patinets with sever mental disorder
10)Patinets judged as inappropriate by attendant doctor
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yosiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65 Tsuruma-cho,showa-ku,Nagoya
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hajime Sumi
Organization Nagoya University Hospital
Division name Department of Gastroenterology
Zip code
Address 65 Tsuruma-cho,showa-ku,Nagoya
TEL 052-744-2602
Homepage URL
Email sumi-h@med.nagoya-u.ac.jp

Sponsor
Institute Department of Gastroenterology,Nagoya University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The result of the 39 subjects 
The mean length of the pancreas was 160.9(128-203 mm), the mean RU was 41.0mm, and the mean UA was 25.3%.
 RU had correlations with BMI (R=0.446, P=0.004) and waist circumference (R=0.354, P=0.027), but no correlations with hematology data .
PU had a strong correlation with RU (R=0.788, P<0.001; linear regression equation: y=0.887x-5.125, R2=0.62)
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
2012 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study was to reveal the unobservable area of pancreatic tail by US and to identify the factors to affect observation of pancreas by using US with position sensor and fusion of US with CT.
mesure outcome:To investigate real unobservable area of pancreatic tail(RU) and predictive length of unobservable area(PU) and We assess the correlation among PU, characteristics of the patients (age, sex,height,body weight,BMI,Girth of the abdomen) and RU.

Management information
Registered date
2012 Year 11 Month 08 Day
Last modified on
2013 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008873

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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