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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036525
Receipt No. R000041478
Scientific Title Radiation exposure for gastrointestinal fluoroscopic procedures. A prospective multicenter observation study
Date of disclosure of the study information 2019/05/01
Last modified on 2019/05/17

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Basic information
Public title Radiation exposure for gastrointestinal fluoroscopic procedures. A prospective multicenter observation study
Acronym REX-GI study
Scientific Title Radiation exposure for gastrointestinal fluoroscopic procedures. A prospective multicenter observation study
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 Department of Gastroenterology,
Toyonaka Municipal Hospital
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 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)

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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
2019 Year 05 Month 17 Day


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

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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