UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between pulse fluoroscopy and conventional fluoroscopy in the ERCP related procedure
Title of the study (Brief title)	Usefulness of pulse fluoroscopy for ERCP related procedure
Region	Japan

Condition
Condition	patients with pancreatobiliary disorders that have indication of ERCP related procedures
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the radiation dose of continuous fluoroscopy conditions with pulse fluoroscopy of 15 per second during ERCP related procedure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is comparison the quality of image of pulse fluoroscopy with that of continuous fluoroscopy that affects clinical practice.
Key secondary outcomes	The secondary endpoint is comparison of radiation dose between two groups.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	pulse fluoroscopy group
Interventions/Control_2	continuous (conventional) fluoroscopy group
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients are more than 19 years of age, suspected pancreatobiliary disorders that have indication of ERCP related procedures, with written informed consent
Key exclusion criteria	The patients are not approved for ERCP related procedure because of general condition.
Target sample size	92

Research contact person
Name of lead principal investigator	Yutaka Shimizu
Organization	Toki Municipal General Hospital
Division name	Depertment of Gastroenterology
Address	703 Tokiguchi Tokitsu-cho Toki city Gifu prefecture Japan
TEL	0572-55-2111
Email

Public contact
Name of contact person	Hiroki Kawashima
Organization	Nagoya University Graduate school of Medicine
Division name	Depertment of Gastroenterology
Address	65 Tsuruma-cho, showa-ku, Nagoya, 466-8550 Japan
TEL	+81-52-744-2602
Homepage URL
Email	h-kawa@med.nagoya-u.ac.jp

Sponsor
Institute	Toki Municipal General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	土岐市立総合病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 22 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 09 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005593