UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Selection of peripheral intravenous catheters with 24-gauge side-holes versus those with 22-gauge end-hole for MDCT
Title of the study (Brief title)	IV contrast infusion via 24-gauge side-holes catheter
Region	Japan

Condition
Condition	All the patients who were referred for a suspect of pancreatic disease are eligible.
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To comparing the 24-gauge side-holes catheter and conventionally used 22-gauge end-hole catheters for the safety, the injection pressure, and the contrast enhancement on multi-detector computed tomography (MDCT).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The safety during intravenous contrast material administration.
Key secondary outcomes	The injection pressure and the contrast enhancement.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Dynamic CT with the 24-gauge side-holes catheter.
Interventions/Control_2	Dynamic CT with the 22-gauge end-hole catheter.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients were randomized if they weighted more than 30 kg, if they were outpatients, and if aged 20 years old or older.
Key exclusion criteria	Exclusion criteria were contraindications to iodinated contrast media, emergency cases, hemodialysis or renal failure patients, pregnant or lactating women, cases unable to place intravenous catheters, and cases with right median cubital vein puncture as an alternative route.
Target sample size	180

Research contact person
Name of lead principal investigator	Akio Tamura
Organization	Iwate Medical University School of Medicine
Division name	Department of Radiology
Address	19-1 Uchimaru, Morioka, Japan
TEL	0196515111
Email	a.akahane@gmail.com

Public contact
Name of contact person	Akio Tamura
Organization	Iwate Medical University School of Medicine
Division name	Department of Radiology
Address	19-1 Uchimaru, Morioka, Japan
TEL	0196515111
Homepage URL
Email	a.akahane@gmail.com

Sponsor
Institute	Iwate Medical University School of Medicine
Institute
Department

Funding Source
Organization	Iwate Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 08 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 21 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S0720048X16303862
Results
Other related information

Management information
Registered date	2016 Year 08 Month 23 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027331