UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009285
Receipt number	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 01:08:14

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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

Biliary tract system and pancreas disease

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

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

Research contact person

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

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 or person

Institute

Department of Gastroenterology,Nagoya University Hospital

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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