UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019138 |
|---|---|
| Receipt number | R000022128 |
| Scientific Title | Previous Pancreatitis and Prolonged Procedure Time in the risk of post-ERCP pancreatitis |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2017/02/22 13:40:32 |
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Basic information
Public title
Previous Pancreatitis and Prolonged Procedure Time in the risk of post-ERCP pancreatitis
Acronym
Previous pancreatitis and time of ERCP in PEP
Scientific Title
Previous Pancreatitis and Prolonged Procedure Time in the risk of post-ERCP pancreatitis
Scientific Title:Acronym
Previous pancreatitis and time of ERCP in PEP
Region
| Japan |
Condition
Condition
post ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the relationship between previous history of pancreatitis and time for cannulation or total procedure time in the risk of PEP
Basic objectives2
Others
Basic objectives -Others
the relationship between previous history of pancreatitis and time for cannulation or total procedure time in the risk of PEP
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the relationship between previous history of pancreatitis and time for cannulation or total procedure time in the risk of PEP
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
more than 20 years old
Key exclusion criteria
None
Target sample size
1335
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Masuda |
Organization
Kobe University Hospital
Division name
Dep. of Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Masuda |
Organization
Kobe University Hospital
Division name
Dep. of Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL
078-382-6305
Homepage URL
atmasuda@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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 | 10 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
retrospective study
The clinical data of consecutive 1,335 ERCP practices performed at Kobe University Hospital from April 2006 to June 2010 were collected.
In this study, the risk factors of PEP are defined as follows considering the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines: female gender, difficulty with cannulation (requiring less than 15 minutes, more than 15 minutes), total procedure time (requiring less than 30 minutes, more than 30 minutes), pancreatic duct injection, pancreatic IDUS, pancreatic juice cytodiagnosis, pancreatic duct brush cytodiagnosis, pre-cut sphincterotomy, previous pancreatitis, and suspected SOD.
Management information
Registered date
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2017 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
