UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037075 |
|---|---|
| Receipt number | R000042246 |
| Scientific Title | Dose the use of low osmolality contrast media reduce the frequency of post-ERCP pancreatitis? : a comparative study between use of low and high osmolality contrast media. |
| Date of disclosure of the study information | 2019/06/15 |
| Last modified on | 2019/06/15 00:10:42 |
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Basic information
Public title
Dose the use of low osmolality contrast media reduce the frequency of post-ERCP pancreatitis? : a comparative study between use of low and high osmolality contrast media.
Acronym
Effect of low osmolality contrast media in post-ERCP pancreatitis
Scientific Title
Dose the use of low osmolality contrast media reduce the frequency of post-ERCP pancreatitis? : a comparative study between use of low and high osmolality contrast media.
Scientific Title:Acronym
Effect of low osmolality contrast media in post-ERCP pancreatitis
Region
| Japan |
Condition
Condition
Gastroenterology
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether low-osmotic contrast agent iodixanol suppresses post-ERCP pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PEP incidence rate by contrast agent
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 28 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ERCP from October 2015 to December 2016.
Key exclusion criteria
Cases treated with nipple treatments such as endoscopic sphincterotomy (EST) and endoscopic papillary balloon dilation (EPBD), cases with underlying malignancy, and cases with acute pancreatitis at the time of ERCP (cholecystolitic inflammation cases) , A case of reconstructed intestinal tract case, a self-expandable metal stent (SEMS) indwelling case, a case in which a pancreatic duct stent was indwelled after ERCP as PEP prevention
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Nagashima |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
321-0293
Address
tochigi,shimotugagunn,mibumachi,kitakobayashi-880
TEL
0282-86-1111
n-kazu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Nagashima |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
321-0293
Address
tochigi,shimotugagunn,mibumachi,kitakobayashi-880
TEL
0282-86-1111
Homepage URL
n-kazu@dokkyomed.ac.jp
Sponsor or person
Institute
oota,memorial,hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
dokkyo-Medical-University
Address
tochigi,shimotugagunn,mibumachi,kitakobayashi-880
Tel
0282-86-1111
n-kazu@dokkyomed.ac.jp
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
| 2019 | Year | 06 | Month | 15 | 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
250
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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2019 | Year | 06 | Month | 15 | Day |
Last modified on
| 2019 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042246
