UMIN-CTR Clinical Trial

Basic information
Public title	Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures
Acronym	REX-GI study
Scientific Title	Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures
Scientific Title:Acronym	REX-GI study
Region	Japan

Condition
Condition	The image guided procedures under fluoroscopic guidance in the field of gastroenterology.
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the actual radiation exposure dose of the imageguided procedures in the field of gastroenterology (ERCP, I nterventional-EUS, enteral SEMS, ileus tube, and balloon-a ssisted endoscopy)
Basic objectives2	Others
Basic objectives -Others	To evaluate the factors affecting the actual radiation expos ure dose
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Radiation exposure dose (Air Kerma (AK) and Dose Area product (DAP)) and fluoroscopy time of each procedure.
Key secondary outcomes	To evaluate the actual radiation exposure dose (RD) and th e following factors. Exposure field of the fluoroscopy, Frame rate, Frequency o f Xray, Factors of each image-guided procedures (ERCP, Interventional EUS, enteral SEMS, ileus tube), Type of disease, treatment and scope, Procedure time, Anesthesia

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients who need image guided procedures under fluoroscopic guidance in the field of gastroenterology under usual clinical care.
Key exclusion criteria	All patients reject to participate in this study via the opt-out method.
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Nishida
Organization	Toyonaka Municipal Hospital
Division name	Gastroenterology
Zip code	560-8565
Address	4-14-1 Shibahara, Toyonaka, Osaka
TEL	06-6843-0101
Email	tnishida.gastro@gmail.com

Public contact
Name of contact person	1st name Tsutomu Middle name Last name Nishida
Organization	Toyonaka Municipal Hospital
Division name	Gastroenterology
Zip code	560-8565
Address	4-14-1 Shibahara, Toyonaka, Osaka
TEL	06-6843-0101
Homepage URL	https://www.chp.toyonaka.osaka.jp/aboutus/kenkyuu/index.html
Email	tnishida.gastro@gmail.com

Sponsor
Institute	Department of Gastroenterology, Toyonaka Municipal Hospital
Institute
Department

Funding Source
Organization	The Japanese Society of Gastroenterology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Toyonaka Municipal Hospital
Address	4-14-1 Shibahara, Toyonaka, Osaka
Tel	06-6843-0101
Email	tnishida.gastro@gmail.com

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

市立豊中病院(大阪府）, 近畿大学付属病院（大阪府）　東京大学医学部付属病院（東京都）、福井県立病院（福井県）、関西労災病院（兵庫県）、大阪市立大学医学部附属病院（大阪府）、石川県立中央病院（石川県）、斗南病院（北海道）、がん研有明病院（東京都）、市立吹田市民病院（大阪府）、大阪労災病院 （大阪府）、 大阪急性期・総合医療センター （大阪府） 、福島県立医科大学附属病院（福島県）、兵庫県立がんセンター（兵庫県）、北野病院（大阪府）、多根総合病院（大阪府）、日本赤十字社医療センター（東京都）、国立病院機構呉医療センター　（広島県）、名古屋市立大学大学院（愛知県）、東邦大学医療センター大橋病院（東京都）、大阪国際がんセンター（大阪府）、岐阜大学医学部附属病院（岐阜県)、東邦大学医療センター大橋病院（東京）、大阪国際がんセンター（大阪）、岐阜大学医学部附属病院（岐阜）、順天堂大学医学部付属医院順天堂医院（東京）

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 01 Day

Related information
URL releasing protocol	https://bmjopen.bmj.com/content/10/2/e033604
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	12416
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	2019 Year 03 Month 26 Day
Date of IRB	2019 Year 04 Month 25 Day
Anticipated trial start date	2019 Year 05 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 01 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	Study design: Multi-center prospective observational study. We examined the procedure time (min), total fluoroscopy time (min), radiation dose (mGy), radiation dose rate (RDR, mGy/min), and dose area product: DAP (mGycm2) during the following procedures. 1) ERCP 2) Interventional EUS 3) Balloon Enteroscopy 4) Enteral Metallic Stent 5) Enteral Long Tube

Management information
Registered date	2019 Year 04 Month 16 Day
Last modified on	2021 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041478