UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031705 |
|---|---|
| Receipt number | R000036208 |
| Scientific Title | A randomized trial of pancreatic stent placement and NSAIDs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis |
| Date of disclosure of the study information | 2018/03/14 |
| Last modified on | 2019/02/18 17:08:59 |
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Basic information
Public title
A randomized trial of pancreatic
stent placement and NSAIDs to
prevent post-endoscopic retrograde
cholangiopancreatography pancreatitis
Acronym
A randomized trial of pancreatic
stent placement and NSAIDs to
prevent post-endoscopic retrograde
cholangiopancreatography pancreatitis
Scientific Title
A randomized trial of pancreatic
stent placement and NSAIDs to
prevent post-endoscopic retrograde
cholangiopancreatography pancreatitis
Scientific Title:Acronym
A randomized trial of pancreatic
stent placement and NSAIDs to
prevent post-endoscopic retrograde
cholangiopancreatography pancreatitis
Region
| Japan |
Condition
Condition
post-endoscopic retrograde
cholangiopancreatography pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
NSAIDs for prevention of post-endoscopic
retrograde cholangiopancreatogrephy
pancreatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The occurrence of post ERCP pancreatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
50mmg of rectal non-steroidal anti-inflamation drugs,30 min before ERCP
Interventions/Control_2
Pancreatic duct stent
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 scheduled to undergo ERCP are included.
Key exclusion criteria
acute pancreatitis,chronic pancreatitis with acute painful exacerbation,peptic ulcer,rectal disease,aspirin-induced asthma,NSAIDs during the preceding 1 week,hypersensitivity to NSAIDs,severe renal dysfunction,pregnant,breast-feeding,inability to provide written informed consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Kato |
Organization
Hyogo prefectural Awaji Medical Center
Division name
Department of Gatroenteterology
Zip code
Address
1-1-17 sumoto,Hyogo,Japan
TEL
0799-22-1200
takao.k@juno.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Kato |
Organization
Hyogo prefectural Awaji Medical Center
Division name
Department of Gatroenteterology
Zip code
Address
1-1-17 sumoto,Hyogo,Japan
TEL
0799-22-1200
Homepage URL
takao.k@juno.ocn.ne.jp
Sponsor or person
Institute
Hyogo prefectural Awaji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
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
Address
Tel
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
| 2018 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036208
