UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036525 |
|---|---|
| Receipt number | R000041478 |
| Scientific Title | Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2021/03/10 09:26:19 |
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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
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
tnishida.gastro@gmail.com
Sponsor or person
Institute
Department of Gastroenterology,
Toyonaka Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041478
