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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031705
Receipt No. 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

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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
Email 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
Email takao.k@juno.ocn.ne.jp

Sponsor
Institute Hyogo prefectural Awaji Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036208

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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