UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016274 |
|---|---|
| Receipt number | R000018884 |
| Scientific Title | effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial- |
| Date of disclosure of the study information | 2015/02/05 |
| Last modified on | 2018/07/04 16:47:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial-
Acronym
a randomized trial of rectal diclofenac and sublingual nitrate for prevention of post ercp pancreatitis
Scientific Title
effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial-
Scientific Title:Acronym
a randomized trial of rectal diclofenac and sublingual nitrate for prevention of post ercp pancreatitis
Region
| Japan |
Condition
Condition
Post-ERCP pancretitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the effi cacy
of rectally administered diclofenac plus sublingual nitrate compared with diclofenac alone to prevent post-ERCP panceatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of post-ERCP pancreatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
patients received a 5mg
of sublingual nitrate before ERCP and received a suppository containing 50mg of diclofenac after ERCP.
Interventions/Control_2
patients received a suppository containing 50mg of diclofenac after 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 are planned ERCP
Key exclusion criteria
1)Patients with performance status 4.
2)Age<20
3)Body weight<50Kg
4)Patients who cannot access to Vater,s papilla.
5)Patients with a history of EST and EPBD.
6)Patients with acute pancreatitis
7)Patients with chronic pancreatitis
8)Patients with pancreatic head tumor
9)Patients who performed operation of reconstraction for intestinal track by gastrectomy.
10) Patients who had a contraindication
to the use of NSAIDs and nitrate.
11) Patients who were already taking nitrates.
12)Patietns without informed concent.
13)Patients who are judged inappropriate by chief medical examiner.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomoda |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
tomotake79@yahoo.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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
| 2015 | Year | 02 | Month | 05 | 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 | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 18 | 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
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2018 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018884
