UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023290 |
|---|---|
| Receipt number | R000025936 |
| Scientific Title | Prophylaxis of post-ERCP pancreatitis using temporary pancreatic stent vs rectal nonsteroidal anti-inflammatory drug: a randomized controlled trial |
| Date of disclosure of the study information | 2016/07/22 |
| Last modified on | 2020/09/17 12:50:50 |
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Basic information
Public title
Prophylaxis of post-ERCP pancreatitis using temporary pancreatic stent vs rectal nonsteroidal anti-inflammatory drug: a randomized controlled trial
Acronym
Prophylaxis of post-ERCP pancreatitis using temporary pancreatic stent vs rectal nonsteroidal anti-inflammatory drug: a randomized controlled trial
Scientific Title
Prophylaxis of post-ERCP pancreatitis using temporary pancreatic stent vs rectal nonsteroidal anti-inflammatory drug: a randomized controlled trial
Scientific Title:Acronym
Prophylaxis of post-ERCP pancreatitis using temporary pancreatic stent vs rectal nonsteroidal anti-inflammatory drug: a randomized controlled trial
Region
| Japan |
Condition
Condition
post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacies of pancreatic stent placement and administration of nonsteroidal anti-infammatory drug to prevent post-ERCP pancreatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the frequency of post-ERCP pancreatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
pancreatic stent placement
Interventions/Control_2
rectal administration of 50mg diclofenac
Interventions/Control_3
pancreatic stent placement and rectal administration of 50mg diclofenac
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. the patients undergoing diagnostic and
therapeutic ERCP examnations
2. documented agreement with informed consent
Key exclusion criteria
1. acute pancreatitis before ERCP
2. contra-indications for NSAIDs
3. patients difficult for pancreatic stent placement
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koshitani |
Organization
Japan Community Healthcare Organization Kobe Central Hospital
Division name
Department of Gastroenterology
Zip code
6511145
Address
2-1-1 Soyama-cho Kita-ku Kobe, 6511145 Japan
TEL
078-594-2211
tkoshitani@aol.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koshitani |
Organization
Japan Community Healthcare Organization Kobe Central Hospital
Division name
Department of Gastroenterology
Zip code
6511145
Address
2-1-1 Soyama-cho Kita-ku Kobe, 6511145 Japan
TEL
078-594-2211
Homepage URL
tkoshitani@aol.com
Sponsor or person
Institute
Japan Community Healthcare Organization Kobe Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Healthcare Organization Kobe Central Hospital
Address
2-1-1 Soyama-cho Kita-ku Kobe, 6511145 Japan
Tel
078-594-2211
tkoshitani@aol.com
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
| 2016 | Year | 07 | Month | 22 | 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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025936
