UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013193 |
|---|---|
| Receipt number | R000015385 |
| Scientific Title | Prophylaxis of post-ERCP pancreatitis by the intravenous administration of the non-steroidal anti-inflammatory drug |
| Date of disclosure of the study information | 2014/02/19 |
| Last modified on | 2014/02/18 20:41:25 |
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Basic information
Public title
Prophylaxis of post-ERCP pancreatitis by the intravenous administration of the
non-steroidal anti-inflammatory drug
Acronym
Intravenous flurbiprofen axetil for prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis
Scientific Title
Prophylaxis of post-ERCP pancreatitis by the intravenous administration of the
non-steroidal anti-inflammatory drug
Scientific Title:Acronym
Intravenous flurbiprofen axetil for prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis
Region
| Japan |
Condition
Condition
Post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the ability of intravenous administration of NSAIDs to prevent Post-ERCP pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The primary outcome is reduction in the rate of post-ERCP pancreatitis, defined as new upper abdominal pain and hyperamylasemia.
Key secondary outcomes
Secondary outcomes included prevention of increase in post-ERCP serum amylase levels and reduction in the severity of PEP.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration of flurbiprofen axetil over 15 min from the start of ERCP
Interventions/Control_2
No intravenous administration of flurbiprofen axetil over 15 min from the start of ERCP
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ERCP
Key exclusion criteria
The following patients were excluded: those with contraindications to flurbiprofen axetil, those who had taken any NSAID during the preceding week, those diagnosed with acute pancreatitis during the month before ERCP, those with an anticipated low risk of PEP (those with chronic calcific pancreatitis or a pancreatic head tumor or those undergoing routine biliary stent exchange), and those who did not agree to participate in the study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shun Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code
Address
1-8-13 Kanda-Surugadai Chiyoda-ku, Tokyo 101-8309 Japan
TEL
03-3293-1711
kobayashi.shun@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shun Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code
Address
1-8-13 Kanda-Surugadai Chiyoda-ku, Tokyo 101-8309 Japan
TEL
03-3293-1711
Homepage URL
kobayashi.shun@nihon-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan
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
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
駿河台日本大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 19 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | 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
| 2014 | Year | 02 | Month | 18 | Day |
Last modified on
| 2014 | 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=R000015385
