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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013193
Receipt No. 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

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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
Email 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
Email kobayashi.shun@nihon-u.ac.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015385

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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