UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004658 |
|---|---|
| Receipt number | R000005549 |
| Scientific Title | A randomized trial of low-dose rectal diclofenac for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis |
| Date of disclosure of the study information | 2010/12/02 |
| Last modified on | 2014/12/09 10:54:48 |
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Basic information
Public title
A randomized trial of low-dose rectal diclofenac for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis
Acronym
A randomized trial of rectal diclofenac for prevention of post ERCP pancreatitis
Scientific Title
A randomized trial of low-dose rectal diclofenac for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis
Scientific Title:Acronym
A randomized trial of rectal diclofenac for prevention of post ERCP 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
In a meta-analysis of four randomized controlled trials (Elmunzer et al. Gut 2008), rectal non-steroidal anti-inflammatory drugs (NSAIDs) were found to be effective for preventing post-ERCP pancreatitis (PEP). The rectal NSAID dosage used in these trials was 100 mg of diclofenac or indomethacin; higher than the normal dosage used in Japan. Therefore, we conducted a prospective randomized controlled trial to evaluate the efficacy of low dose rectal NSAIDs for prevention of PEP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence of PEP as defined by the criteria of Cotton as the development of abdominal pain and elevation of serum amylase level greater than three times the upper normal limit within 24 hours after ERCP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Diclofenac group is administered with 50 mg of rectal diclofenac 30 min before ERCP with saline infusion (for patients weighing less than 50 kg, the dose of diclofenac was reduced to 25 mg).
Interventions/Control_2
Control group is administered with saline infusion only.
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
Patients who are planned ERCP.
Key exclusion criteria
Patients with acute or chronic pancreatitis.
Patients with a history of endoscopic sphincterotomy.
Patients who are diagnosed peptic ulcer disease.
Patients with a history of aspirin-induced asthma.
Patients with rectal diseases.
Patients who are treated with triamterene.
Pregnant and breast-feeding women.
Patients who had taken NSAIDs during preceding week.
Patients with a history of hypersensitivity to NSAIDs.
Patients with a severe renal dysfunction.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Kawazoe |
Organization
Saga Prefectural Hospital KOSEIKAN
Division name
Hepatobiliary and Pancreatic Medicine
Zip code
Address
1-12-9, Mizugae, Saga-shi, Saga
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Otsuka |
Organization
Saga Prefectural Hospital KOSEIKAN
Division name
Hepatobiliary and Pancreatic Medicine
Zip code
Address
1-12-9, Mizugae, Saga-shi, Saga
TEL
Homepage URL
Sponsor or person
Institute
Saga Prefectural Hospital KOSEIKAN
Institute
Department
Personal name
Funding Source
Organization
None.
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | 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
| 2010 | Year | 12 | Month | 02 | Day |
Last modified on
| 2014 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005549
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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